(80 days)
MICROHYBRID 11 is to be used as a filling material for restoring function to teeth that have lost portions due to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV
Class V restorations, cervical caries, root erosion, wedge shaped defects.
Posterior restorations, Class I, II.
Splinting of mobile teeth.
Preventive restorations in molars and premolars.
Repair of composite and ceramic veneers.
Inlays/onlays with extra-oral post tempering
Not Found
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) premarket notification letter for a dental device called "Microhybrid 11," primarily focusing on its substantial equivalence determination. It lacks details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 2002
AB ARDENT C/O Mr. Clyde E. Ingersoll Ardent Product Development 54 Riverview Avenue Tonawanda. New York 14150
Re: K022971
Trade/Device Name: Microhybrid 11 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 13, 2002 Received: November 18, 2002
Dear Mr. Ingersoll,
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.
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Page 2 - Mr. Clyde E. Ingersoll
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
nclosure
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AB ARDENT
Generatorgatan 8 S-195 60 Marsta Sweden Phone +046 8 591 210 20 FAX +046 8 591 161 83
510 (k) MICROHYBRID 11 ATTACHMENT #4
INDICATIONS FOR USE
Indications:
MICROHYBRID 11 is to be used as a filling material for restoring function to teeth that have lost portions due to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV
Class V restorations, cervical caries, root erosion, wedge shaped defects.
Posterior restorations, Class I, II.
Splinting of mobile teeth.
Preventive restorations in molars and premolars.
Repair of composite and ceramic veneers.
Inlays/onlays with extra-oral post tempering
Contra indications:
The placement of Microhybrid 11 is contraindicated
If a dry working field cannot be established or if the stipulated technique cannot be applied.
If the patient is known to be allergic to the components of Microhybrid 11.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Robert Betz DDS for Dr. Susan Kunnel
y, General Hospital
510(k) Number: K022971
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.