(281 days)
The OrthoSlenderizer is intended for use as a method of achieving interproximal enamel reduction of teeth using a reciprocal movement.
Not Found
The provided text is an FDA 510(k) clearance letter for a device called "OrthoSlenderizer." It primarily addresses regulatory approval and does not contain information on acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Name: OrthoSlenderizer
- Regulation Number/Name: 21 CFR 872.4200, Dental Handpiece and Accessories
- Regulatory Class: I
- Product Code: EFB
- FDA Determination: Substantially equivalent to legally marketed predicate devices.
- Intended Use: "as a method of achieving interproximal enamel reduction of teeth using a reciprocal movement."
To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or the actual study report submitted with the 510(k) application.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Paul A. Rocke Orthomatics, Incorporated 200 West County Line Road #340 Highlands Ranch, Colorado 80129
FEB - 8 2012
Re: K111249
Trade/Device Name: OrthoSlenderizer Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: April 21, 2011 Received: February 6, 2012
Dear Dr. Rocke:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.
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Page 2- Dr. Rocke
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runnee
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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111249
Intended Use
The OrthoSlenderizer is intended for use as a method of achieving interproximal enamel reduction of teeth using a reciprocal movement.
Susan Rummer
(Division Sign-Off) (Division Sign-Dit)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anoothoon Control, Devices
510(k) Number: K111249
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.