BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES

K100785 · Bonart Co., Ltd. · EBW · Dec 3, 2010 · Dental

Device Facts

• Record ID: K100785
• Device Name: BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
• Applicant: Bonart Co., Ltd.
• Product Code: EBW · Dental
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ART-IM1 Implantor is an implant machine system. It is primarily used by dental professionals in doing oral implant surgery or implantology such as drilling, reaming, cutting, etc. This system is also used for fixing previous broken or failed implant procedure.

Device Story

The Bonart ART-IM1 Implantor is a dental handpiece system used by dental professionals in clinical settings for oral implantology. The device provides mechanical power for surgical tasks including drilling, reaming, and cutting bone or tissue during implant placement or revision of failed procedures. It functions as a standard dental surgical motor system. The operator controls the device to perform precise mechanical actions required for implant site preparation. The output is the mechanical rotation of surgical burs or drills, which facilitates the surgical procedure and aids the clinician in achieving the desired clinical outcome for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental handpiece system; mechanical motor-driven; intended for drilling, reaming, and cutting; Class II device; Product Code EBW.

Indications for Use

Indicated for dental professionals performing oral implant surgery, including drilling, reaming, and cutting, or for corrective procedures on failed implant sites.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Bonart Company Limited C/O Mr. Eric L. Ong Bonart Medical Technology, Incorporated 398 S. Lemon Creek Drive, Suite G Walnut, California 91789

DEC - 3 2010

Re: K100785

Trade/Device Name: BonartART-IM1 Implantor System & Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: II Product Code: EBW Dated: October 25, 2010 Received: October 27, 2010

Dear Mr. Ong:

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 Federal Register.

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Page 2- Mr. Ong

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 (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.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

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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## INDICATION FOR USE

510(k) Number: To be assigned by FDA

K100785

Device Name: BonartART-IM1 Implantor System & Accessories

Indication for Use: The ART-IM1 Implantor is an implant machine system. It is primarily used by dental professionals in doing oral implant surgery or implantology such as drilling, reaming, cutting, etc. This system is also used for fixing previous broken or failed implant procedure.

DEC - 3 2010

Prescription Use (Part 21 CFR 801 Subpart D)

And /Or

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K100785