← Product Code [ELC](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC) · K082973 # STER-MATE STERILE LAVAGE KIT (K082973) _Dentsply Interntional · ELC · Jan 29, 2009 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K082973 ## Device Facts - **Applicant:** Dentsply Interntional - **Product Code:** [ELC](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC.md) - **Decision Date:** Jan 29, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4850 - **Device Class:** Class 2 - **Review Panel:** Dental ## Intended Use The Cavitron Steri-Mate Handpiece Sterile Lavage Kit is indicated for use with the DENTSPLY Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery. ## Device Story The Cavitron Steri-Mate Handpiece Sterile Lavage Kit is an accessory for DENTSPLY Cavitron Ultrasonic Scalers. It enables the delivery of sterile lavage fluid during dental procedures. The kit consists of a pressurized infuser bag, which hangs from an IV pole, and a Steri-Mate Handpiece Adapter. The adapter is installed between the handpiece cable and the existing Steri-Mate handpiece. The device does not alter the operation of the ultrasonic scaler itself. It is used by dental clinicians in a clinical setting to facilitate sterile irrigation during the removal of calculus, plaque, and stain. By allowing the use of an external sterile water source, the kit helps maintain a sterile field during periodontal and prophylactic treatments. ## Clinical Evidence Bench testing only. Validation of the ability to deliver sterile lavage was performed according to United States Pharmacopeia (31), National Formulary (26), 2008, Chapter <71> Sterility Test. Results documented the system is capable of delivering sterile solutions when assembled as directed. ## Technological Characteristics Accessory kit consisting of a pressurized infuser bag and a handpiece adapter. No active electronic components. Does not require IEC 60601-1 testing. Designed for use with existing Cavitron Ultrasonic Scalers. Sterility validation performed per USP <71>. ## Regulatory Identification An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth. ## Predicate Devices - Steri-Mate Handpiece for Cavitron Jet ([K941392](/device/K941392.md)) ## Related Devices - [K023697](/device/K023697.md) — STERI-MATE STERILIZABLE HANDPIECE · Dentsply International · Nov 6, 2002 - [K041124](/device/K041124.md) — IRRIGATION TUBING SET 2.2M AND 3.8M · W&H Dentalwerk Burmoos · Jun 7, 2004 - [K163414](/device/K163414.md) — Ultrasonic scaler · Nanning VV Dental Co., Ltd. · Nov 21, 2017 - [K080089](/device/K080089.md) — SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS · Sybron Dental Specialties, Inc. · Sep 4, 2008 - [K991035](/device/K991035.md) — QUANTEC-E IRRIGATION SYSTEM · Sybron Dental Specialties, Inc. · Jun 24, 1999 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The word is horizontally oriented and appears to be a logo or brand name. K082973 JAN 2 9 2009 Cavitron Steri-Mate Handpiece Sterile Lavage Kit ### DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 (717) 845-7511 (voice) 717) 849-4343 (fax) www.dentsply.com # 510(k) SUMMARY for ### Cavitron Steri-Mate Handpiece Sterile Lavage Kit - Submitter Information: 1. DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405 | Contact Person: | Helen Lewis | |-------------------|--------------| | Telephone Number: | 717-849-4229 | | Fax Number: | 717-849-4343 | Date Prepared: October 2, 2008 Ultrasonic Scaler § 872.4850 Class II ELC #### 2. Device Name: - Proprietary Name: � - Classification Name: ● - CFR Number: . - Device Class: . - Product Code: . #### 3. Predicate Device: DENTSPLY International Company: Steri-Mate Handpiece for Cavitron Jet Device: 510(k) No .: K941392 Date Cleared: 05/23/1994 #### 4. Description of Device: The Cavitron® Steri-Mate® Handpiece Sterile Lavage Kit is an accessory for Cavitron® Ultrasonic Scalers that use the 30K Steri-Mate® Sterilizable Handpiece. This kit is intended to provide the clinician with a method to use sterile lavage DENTSPLY International 00012 {1}------------------------------------------------ with a Cavitron® Ultrasonic Scaler. The kit consists of a pressurized infuser bag and a Steri-Mate Handpiece Adapter. The Pressurized Infuser bag can be hung from a standard IV pole or similar device. The Steri-Mate Handpiece Adapter is easily installed between the handpiece cable and the Steri-Mate Handpiece. The adapter does not affect the operation of the Cavitron® Unit or the Steri-Mate Handpiece. #### ર. Indications for Use: The Steri-Mate Handpiece Sterile Lavage Kit is intended for use with a Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery. #### 6. Description of Safety and Substantial Equivalence: # Technological Characteristics The Steri-Mate Handpiece Adapter is an accessory for the currently marketed Steri-Mate Handpiece for Cavitron Jet (K941392). The Adapter has been verified to function with the Steri-Mate Handpiece for Cavitron Jet. Additionally, comparative operations demonstrate that the Steri-Mate Handpiece Sterile Lavage Kit maintains the same performance to ultrasonically remove material from dental surfaces with the currently marketed device. # Non-Clinical Performance Data. - The Steri-Mate Handpiece Sterile Lavage Kit contains no active electronic . components. The Steri-Mate Handpiece Adapter allows the use of an external sterile water source. The source is not supplied with the product. Therefore, testing to IEC 60601-1 was considered not necessary based on engineering considerations. - . Validation of the ability of the Sterile Lavage Handpiece Adapter Kit to deliver sterile lavage was tested to the procedures described in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter <71> Sterility Test. Results have documented that the system is capable of delivering sterile solutions when assembled as directed in the Directions for Use. # Conclusion as to Substantial Equivalence The results of testing demonstrate that the use of sterile fluid as a source of lavage is as safe, effective and performs as well to the currently-marketed predicate device. DENTSPLY International {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol. The logo is black and white. ### Public Health Service ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Helen Lewis · Director, Corporation Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street Suite 60 York, Pennsylvania 17405-0872 JAN 2 9 2009 Re: K082973 > Trade/Device Name: Steri-Mate Handpiece Sterile Layage Kit Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 22, 2009 Received: January 23, 2009 ### Dear Ms. Lewis: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Anthony D. Watson for Ginette Y. Michaud, M.D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Device Name: Steri-Mate Handpiece Sterile Lavage Kit ### Indications for Use: The Cavitron Steri-Mate Handpiece Sterile Lavage Kit is indicated for use with the DENTSPLY Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery. 1082973 Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) 000011 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Renne (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K082973 DENTSPLY International Cavitron Steri-Mate Handpiece Sterile Lavage Kit --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K082973](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K082973) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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