SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)

{0}------------------------------------------------ K032995 Page 1/2 ## 6. 510 (k) Summary of Safety and Effectiveness (revised) 510 (k) number k032995 Air Scaler SSS [As required by 21 CFR 807.87 (h) ] ### 6.1 Submitter Identification Establishment: | Owner / Operator Number: | |------------------------------------| | Establishment Registration Number: | | Telephone Number: | | Fax Number: | | Official Correspondent: | | E-mail Address: | | Date of Summary Preparation: | #### 6.2 Product Identification Device Trade Name: Classification Panel: Classification Name: Common Name: Product Code: Regulatory Class: Micron Corporation 1-34-14, Higashiyukigaya Ota-ku, Tokyo, 145-0065 Japan 9037104 9614726 +81-3-3726-0396 +81-3-3726-5396 Takashi Terui (Mr.) terui@micdent.com November 13th, 2003 - ਫੜ੍ Dental Scaler Ultrasonic, per 21 CFR 872.4850 Air Scaler ELC Class II Models: SSS 4H (with standard 4-hole coupling), product number 1072001 SSS 2H (with standard 2-hole coupling), product number 1072002 #### 6.3 Identification of Legally Marketed Predicate Device | A - E P P P - S - S - S - S - S - S - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------| | Device | Manufacturer | 510 (k) Number | | Air scaler VIP 60 | Micron Corporation | K991239 | #### 6.4 Device Description As with its predicate device, SSS is an air scaler for use by dental professionals. The basic design of the predicate and modified devices are same: both are made in the shape of handpiece like dental turbines, used on a dental treatment unit and activated by compressed air delivered from the dental unit. The common operation principle to the predicate is used in the modified device: When the compressed air runs into scaler's built-in vibratory cartridge, it generates elliptical movement of the scaling tip mounted. The scaling tip movement removes dental calculus, plaque or stain from teeth. {1}------------------------------------------------ # 6. 510 (k) Summary of Safety and Effectiveness (revised) Page 2/2 510 (k) number k032995 [As required by 21 CFR 807.87 (h) ] Micron Corporation Submitter/Manufacturer: 1-34-14, Higashiyukigaya, Ota-ku, Tokyo, 145-0065 JAPAN Air scaler SSS Product name: #### 6.5 Indications for Use SSS is intended for the applications below in the area of dental treatment by dental professionals. · Removal of dental calculus, plaque or stain #### 6.6 Description of Modification The running noise of SSS is substantially reduced by applying vibration frequency of 16.000 to 17.000 Hz for increased comfort of the user and patient, while the predicate device has frequency of 5,000 to 6,000 Hz and emits audible noise. The vibration cartridge is redesigned so that the user can easily replace in his / her dental office. #### 6.7 Standards Met 1) ISO 15606 : 1999 - Dental handpieces -- Air-powered scalers and scaler tips 2) EN 1639 : 1996 - Dentistry - Medical devices for dentistry - Instruments 3) AAMI / ISO 14971-1 : 1998 - Medical Devices - Risk Management - Part 1: Application of risk analysis (General) #### 6.8 Summary of Design Control Activities The risk analysis method to assess the impact of the modifications was based on a Failure Modes and Effects Analysis (FMEA). This analysis built upon the risk analysis of the predicate device. #### 6.9 Substantial Equivalence Conclusion The modified air scaler SSS has the following commonalities to its predicate device: - · the equivalent indication of use, - · the same operating principle applied, - · the same basic product design, - · conformity to the same and similar standards Thus we believe the Micron SSS described in this submission has the substantial equivalence to the predicate device, submitter's VIP 60 air scaler. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 0 2003 Micron Corporation Mr. Takashi Terui Manager, Overseas Division 1-34-14, Higashiyukigaya Ota-Ku, Tokyo, 145-0065 Japan Re: K032995 Trade/Device Name: Air Scaler SSS Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: November 14, 2003 Received: November 17, 2003 Dear Mr. Terui: 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}------------------------------------------------ #### Page 2 - Mr. Terui 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 (QS) 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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Shih-Lin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 510(k) Number (if known):__k032995 Device Name: Air scaler SSS This air scaler is intended to remove dental plaque, Indications For Use: calculus and stain from tooth surface or root by dental professionals only. Susan Rump (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: IC-32043 (Please Do NoT WRITE Below This LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)