MICROHYBRID 12

K022974 · Ab Ardent · EBF · Nov 22, 2002 · Dental

Device Facts

• Record ID: K022974
• Device Name: MICROHYBRID 12
• Applicant: Ab Ardent
• Product Code: EBF · Dental
• Decision Date: Nov 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MICRCHYBRID 12 is to be used as a filling material for restoring function to teeth which 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. Inlavs/onlays with extra-oral post tempering

Device Story

Microhybrid 12 is a dental restorative material used by dentists to fill cavities and restore tooth function. Applied directly to prepared tooth surfaces following caries removal; used for anterior and posterior restorations, splinting, and veneer repair. Material provides structural replacement for lost tooth tissue. Clinical benefit includes restoration of dental function and aesthetics. Device is for professional use only; not for OTC or public use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tooth shade resin material. Class II device. Intended for direct, fixed dental restorations.

Indications for Use

Indicated for dental patients requiring restoration of tooth structure lost to caries, including Class I-V restorations, splinting of mobile teeth, preventive restorations, and repair of veneers. Contraindicated if a dry working field cannot be maintained or if the patient has known allergies to device components. For use by dental professionals (DDS/DMD) only.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

NOV 22 2002

AB Ardent C/O Mr. Clyde E. Ingersoll Ardent Product Development 54 Riverview Avenue Tonawanda, New York 14150-5260

Re: K022974

Trade/Device Name: MICROHYBRID 12 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 5, 2002 Received: September 6, 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 vour 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. 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 (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Patrice Cucinello

Timothy A. Ulatowski 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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AB ARDENT
Generatorgatan 8
S. 195 60 Marsta.
K022974
S'vederi
Phone [phone]
FAX [phone]

# MICROHYBRID 12 ATTACHMENT #4

#### INDICATIONS FOR USE

#### ludications:

MICRCHYBRID 12 is to be used as a filling material for restoring function to teeth which have lost portions due to caries:

IDirect, 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.

Inlavs/onlays with extra-oral post tempering

#### ( :ontra indications:

1 he pliacement of Microhybrid 12 is contraindicated

If a dry working field cannot be established or if the stipulated technique cannot the applied.

If the patient is known to be allergic to the components of Microhybrid 12.

# I or use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Dr. Robert Betz for Dr. Susan Kummer

n of Anesthesidlogy, General Hospital. Infection Control, Dental Devices

510(k) Number: K022974