TF3-DPD73227323Base Transmitter

8/16/2005 CavitronRF Scaler - DFU Draft 08-01-05.doc Page 1 of 13 Cavitron RF Ultrasonic Scaler Directions for Use -Draft Form- Rev-1 04/26/05 Rev-2 06/24/05 Rev-3 06/27/05 Rev-4 06/28/05 Rev-5 07/07/05 Rev-6 07/13/05 Rev-7 07/18/05 Rev-8 07/22/05 Rev-9 07/25/05 Rev-10 08/01/05 8/16/2005 CavitronRF Scaler - DFU Draft 08-01-05.doc Page 2 of 13 Introduction Welcome to the world of ultrasonic scaling as experienced with a Cavitron ® ultrasonic scaling system, the original brand of ultrasonic scaling systems. Your decision to add the Cavitron ® RF™ Ultrasonic Scaler from DENTSPLY Professional to your practice represents a wise investment in good dentistry. Congratulations! For over four decades, dental professionals have discovered the clinical benefits and labor-saving advantages inherent in Cavitron ultrasonic scalers. Clinical studies and independent research have proven that no other method of supra- and subgingival calculus removal can surpass the speed, efficiency, and versatility of ultrasonic scaling. DENTSPLY® Professional is an ISO 13485 registered company. All DENTSPLY Professional medical devices sold in Europe are CE marked in conformance with Council Directive 93/42/EEC. Website: www.professional.dentsply.com Caution: Federal law restricts this device to sale by or on the order of a Dentist. Product Overview The Cavitron® RF™ ultrasonic scaling system is a precision engineered and manufactured instrument. It contains controls and components for ultrasonic scaling. The system produces 30,000 strokes per second at the ultrasonic insert’s working tip that when combined with the cavitational effect of the coolant lavage creates a synergistic action that literally “powers away” the heaviest calculus deposits while providing exceptional operator and patient comfort. Technological advances in the Cavitron RF system, including a wireless footswitch, easy to view illuminated display, 330° swivel handpiece cable with lavage control, Steri-Mate™ Plus detachable sterilizable handpiece, rinse setting, automated purge function, and Expanded SPS™ Technology, combine with established features like The Blue Zone™ extended low power range and Hands-Free Boost mode, to provide the ultimate in ultrasonic scaling experiences for both you and your patient while still providing the quality and reliability you’ve come to expect from Cavitron Brand ultrasonic systems. Your Cavitron® RF™ combination system is UL/CSA certified and approved. The Cavitron® RF Combination System is classified by Underwriters Laboratories Inc. with respect to electric shock, fire, mechanical hazards in accordance with IEC 60601 Standard. The Cavitron RF Combination System complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation. Cavitron RF base FCC certification/registration number: FCC ID: TF3- DPD73227323; IC: 4681B-73227323. Cavitron RF footswitch FCC certification/registration number: FCC ID: TF3-DPD81675; IC: 4681B-81675. The term IC before the certification/registration number only signifies that the Industry Canada technical specifications were met. Technical Support For technical support and repair assistance in the U.S., call DENTSPLY Professional Cavitron Care SM Factory Certified Service at 1-800-989-8826, Monday through Friday, 8:00 A.M. to 5:00 P.M. (Eastern Time). For other areas, contact your local DENTSPLY ® Professional Representative. Supplies & Replacement Parts To order supplies or replacement parts in the U.S., contact your local DENTSPLY® Professional Distributor or call 1-800-989-8826, Monday through Friday, 8:00 A.M. to 5:00 P.M. (Eastern Time). For other areas, contact your local DENTSPLY ® Professional Representative. 8/16/2005 CavitronRF Scaler - DFU Draft 08-01-05.doc Page 3 of 13 Section 1: Indications For Use Ultrasonic procedures: All general supra and subgingival scaling applications. • Periodontal debridement for all types of periodontal diseases. • For patients with a history of sensitivity to ultrasonic scaling. • Endodontic procedures. Section 2: Contraindications and Warnings 2.1 Contraindications • Ultrasonic Systems should not be used for restorative dental procedures involving the condensation of amalgam. 2.2 Warnings • Persons fitted with cardiac pacemakers, defibrillators and other active implanted medical devices, have been cautioned that some types of electronic equipment might interfere with the operation of the device. Although no instance of interference has ever been reported to DENTSPLY, we recommend that the handpiece and cables be kept at least 6 to 9 inches (15 to 23 cm) away from any device and their leads during use. There are a variety of pacemakers and other medically implanted devices on the market. Clinicians should contact the device manufacturer or the patient’s physician for detailed information about the device. • The use of High Volume Saliva Evacuation to reduce the quantity of aerosols released during treatment is highly recommended. • It is the responsibility of the Dental Healthcare Professionals (DHCP) to determine the appropriate uses of this product and to understand the health of each patient, the dental procedures being undertaken, and industry and governmental agency recommendations, requirements, and regulations for safe practice of dentistry. • Where asepsis is required or deemed appropriate in the best professional judgment of the DHCP, this product should not be used. • During boil-water advisories, this product should not be operated as an open water system (e.g. connected to a public water system). DHCP should discontinue use on patients and contact the local water authority to determine when it is safe to continue use of this product. When the advisory is cancelled, the local water authority should provide guidance for flushing of waterlines. Al…

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FCC A U T H O R I Z A T I O N Date: 06/16/05 Time: 11:25 To: FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, MD 21045-0429 From: Kevin Lint Phone: 717-767-8500 Engineering manager Fax: 717-767-8273 Applicant: Dentsply Professional Div. E-Mail: [email protected] ________________________________________________________________________ Dear Ladies and/or Gentlemen: I appoint Kenneth L. Boston, James Blaha and Teresa White at L.S. Compliance, Inc., to act as an agent in the preparation of applications under Part 15 of the rules and regulations of the Federal Communications Commission. I certify that the exhibitions properly describe the device being submitted under this application and will implement any changes described in the test report. The labels described will be affixed to each item. The following statement is required by the Federal Communications Commission: By checking Yes, the applicant certifies that, in the case of an individual applicant, he or she is not subject to a denial of federal benefits, that included FCC benefits, pursuant to section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C 853(a), or, in the case of a non- individual applicant (e.g. corporation, partnership, or other unincorporated association), no party to the application is subject to a denial of federal benefits, that includes FCC benefits, pursuant to that section. ___X___Yes _______No By: Kevin Lint Title: Engineering Manager / Dentsply Professional DENTSPLY International Inc. Professional Division 1301 Smile Way York, PA 17404-1785 1-800-989-8825 (717) 767-8500

FCC CONFIDENTIALITY Date: 06/30/05 Time: 8:55 To: FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, MD 21045-0429 From: Kevin Lint Phone: 717-767-8605 Engineering Manager Fax: 717-767-8273 Applicant: Dentsply Professional Division. E-Mail: [email protected] ________________________________________________________________________ Subject: Request for Non disclosure for FCC ID: TF3–DPD73227323. To Whom It May Concern: Pursuant to 47 CFR Section 0.459, ( Dentsply Professional Division ) hereby requests non disclosure and confidential treatment of the following materials submitted in support of FCC certification application for FCC ID # (TF3–DPD73227323.) a. Schematic Diagrams b. Operational Description c. Block Diagram Above materials contain trade secrets, proprietary and technical information which would customarily be guarded from competitors under 47 CFR section 0.457(d)(2). Disclosure or publication of any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. (Dentsply Professional Division) understands that pursuant to 47 CFR section 0.457(d)(1)(ii) disclosure of the applicant and all accompanying documentation will not be made before the date of the grant. Sincerely yours, By: Kevin Lint Title: Engineering Manager / Dentsply Professional Division ______________________________________________________________________________________ DENTSPLY International Inc. Professional Division 1301 Smile Way York, PA 17404-1785 1-800-989-8825 (717) 767-8500

Dentsply Professional Division Cavitron Base FCC ID#: TF3-DPD73227323 Photo One – External Front View Dentsply Professional Division Cavitron Base FCC ID#: TF3-DPD73227323 Photo Two – External Back View Dentsply Professional Division Cavitron Base FCC ID#: TF3-DPD73227323 Photo Three – External Close-up of FCC ID Label

Dentsply Professional Division Cavitron Base FCC ID#: TF3-DPD733227323 Photo One – Internal Open for Inspection Dentsply Professional Division Cavitron Base FCC ID#: TF3-DPD733227323 Photo Two – Internal Dentsply Professional Division Cavitron Base FCC ID#: TF3-DPD733227323 Photo Three – Internal Dentsply Professional Division Cavitron Base FCC ID#: TF3-DPD733227323 Photo Four – Internal Dentsply Professional Division Cavitron Base FCC ID#: TF3-DPD733227323 Photo Five – Internal Dentsply Professional Division Cavitron Base FCC ID#: TF3-DPD733227323 Photo Six – Internal

L.S. Compliance, Inc. W66 N220 Commerce Court Cedarburg, WI 53012 262-375-4400 Fax: 262-375-4248 COMPLIANCE TESTING OF : Dentsply Cavitron SPS RF Base Unit, Gen-131 and Gen 132 Prepared For: Dentsply International Attention: Mr. Kevin Lint 1301 Smile Way York, PA 17404-0807 Test Report Number: 305305-Tx-v1 Test Dates: June 16 H through August 16 TH , 2005 All results of this report relate only to the items that were tested. This report is not to be reproduced, except in full, without written approval of L. S. Compliance, Inc. L.S. Compliance, Inc. Page 2 of 32 Test Report Number: 305305-Tx-V1 Prepared For: Dentsply International Table of Contents Section Description Page Index 2 1 L. S. Compliance in Review 3 2 A2LA Certificate of Accreditation 4 3 Validation Letter-U.S. Competent Body for EMC Directive 89/336/EEC 5 4 Signature Page 6 5 Product and General Information 7 6 Introduction 7 7 Product Description 8 8 Test Requirements 9 9 Summary of Test Report 9 10 Radiated Emissions Test 10-22 11 Conducted RF Emissions onto AC Power Line 23-27 12 Band-Edge Measurements 28-29 13 Frequency and Power Stability Requirements 30 Appendix A Test Equipment List 31 B Antenna Specifications 32 L.S. Compliance, Inc. Page 3 of 32 Test Report Number: 305305-Tx-V1 Prepared For: Dentsply International 1. L. S. Compliance In Review L.S. Compliance - Accreditations and Listing’s As an EMC Testing Laboratory, our Accreditation and Assessments are recognized through the following: A2LA – American Association for Laboratory Accreditation Accreditation based on ISO/IEC 17025 : 1999 with Electrical (EMC) Scope of Accreditation A2LA Certificate Number: 1255.01 Federal Communications Commission (FCC) – USA Listing of 3 Meter Semi-Anechoic Chamber based on Title 47 CFR – Part 2.948 FCC Registration Number: 90756 Listing of 3 and 10 meter OATS based on Title 47CFR – Part 2.948 FCC Registration Number: 90757 Industry Canada On file, 3 Meter Semi-Anechoic Chamber based on RSS-212 – Issue 1 File Number: IC 3088-A On file, 3 and 10 Meter OATS based on RSS-212 – Issue 1 File Number: IC 3088 U. S. Conformity Assessment Body (CAB) Validation Validated by the European Commission as a U. S. Competent Body operating under the U. S. /EU, Mutual Recognition Agreement (MRA) operating under the European Union Electromagnetic Compatibility –Council Directive 89/336/EEC, Article 10.2. Date of Validation: January 16, 2001 Validated by the European Commission as a U.S. Notified Body operating under the U.S./EU, Mutual Recognition Agreement (MRA) operating under the European Union Telecommunication Equipment – Council Directive 99/5/EC, Annex V. Date of Validation: November 20, 2002 Notified Body Identification Number: 1243 L.S. Compliance, Inc. Page 4 of 32 Test Report Number: 305305-Tx-V1 Prepared For: Dentsply International 2. A2LA Certificate of Accreditation L.S. Compliance, Inc. Page 5 of 32 Test Report Number: 305305-Tx-V1 Prepared For: Dentsply International 3. Validation Letter – U.S. Competent Body for EMC Directive 89/336/EEC L.S. Compliance, Inc. Page 6 of 32 Test Report Number: 305305-Tx-V1 Prepared For: Dentsply International 4. Signature Page Prepared By: August 16, 2005 Teresa A. White, Document Coordinator Date Tested By: August 16, 2005 Abtin Spantman, EMC Engineer Date Approved By: August 16, 2005 Kenneth L. Boston, EMC Lab Manager Date PE #31926 Licensed Professional Engineer Registered in the State of Wisconsin, United States L.S. Compliance, Inc. Page 7 of 32 Test Report Number: 305305-Tx-V1 Prepared For: Dentsply International 5. Product and General Information Manufacturer: Dentsply International Date(s) of Test: June 16 th through August 16 th , 2005 Test Engineer(s): Tom Smith √ Abtin Spantman Ken Boston Model #: Cavitron SPS RF Base Unit Serial #: Engineering Sample Voltage: 100 to 230 VAC, 50 to 60 Hz Operation Mode: Normal, and continuous transmit with modulation 6. Introduction Between June 16 th and August 16 th , 2005, a series of Conducted and Radiated Emission tests were performed on one sample of the Dentsply Internationals’ Cavitron SPS RF Base Unit, Gen-131, here forth referred to as the “Equipment Under Test” or “EUT”. These tests were performed using the procedures outlined in ANSI C63.4-2003 for intentional radiators, and in accordance with the limits set forth in 47 CFR Part 15 (Industry Canada RSS-210) for a low power transmitter, and 47 CFR Part 18 for Ultrasonic equipment. These tests were performed, in part, for demonstration of compliance to the aforementioned standards. These tests, along with further testing, as carried out by Underwriters Laboratories, Incorporated (UL), and covered in the UL report for project number: “05ME06294”, File: “E175103”, demonstrates the complete suite of testing carried out on these products. The test results presented here, along with testing performed at UL serves to demonstrate compliance for the family of the Dentsply Cavitron products, including Gen-131 and Gen-132 variations. The radio testing on the Dentsply RF Footswitch, considered as a peripheral device to the Cavitron Base Unit, is covered in LS Compliance report number 305306-nn-vn. The tests at L.S. Compliance were performed by Abtin Spantman, EMC Engineer of L.S. Compliance, Inc. and witnessed, in part, by Mr. Kevin Lint of Dentsply International. All Radiated and Conducted Emission tests were performed upon the EUT to measure the emissions in the frequency bands described in FCC Title 47 CFR Part 15, including 15.35, 15.207, 15.209, 15.249, 18.107, 18.305, 18.307 and Industry Canada RSS-210 to determine whether these emissions are below the limits expressed within the standards. These tests were performed in accordance with the procedures described in the American National Standard for methods of measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz (ANSI C63.4-2003). Another document used as a reference for the EMI Receiver s…

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TEST SETUP PHOTOS DENTSPLY - BASE Front v iew of the EUT showing ultrasonic wand on the right side Front view of the EUT showing the test programming fixture on the left side. View of the EUT showing the setup on a pedestal during radiated emissions testing In stand-by mode. View of the EUT showing the setup on a pedestal during radiated emissions testing In active mode with the water supply. View of the EUT during the conducted emissions onto AC mains.