ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE

K992838 · Biomat Sciences, Inc. · KLE · Nov 15, 1999 · Dental

Device Facts

• Record ID: K992838
• Device Name: ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE
• Applicant: Biomat Sciences, Inc.
• Product Code: KLE · Dental
• Decision Date: Nov 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Adhere is used to bond restorative materials to enamel and dentin. The materials include composites, compomers, amalgam, ceramic veneers and ceramic inlays. In addition, Adhere is used to seal dentin, and reduce tooth sensitivity in non-bacterial mediated cervical lesions of teeth. Adhere is also used to promote composite bonds to ceramics and metals.

Device Story

Adhere is a dental adhesive system; consists of surface conditioners, primers, adhesive resin, initiators, and application accessories. Used by dentists to bond restorative materials (composites, compomers, amalgam, ceramics, metals) to tooth structure (enamel/dentin). Procedure involves tooth conditioning, primer application, and adhesive resin overlayer placement to facilitate chemical bonding. Also used to seal dentinal tubules to reduce sensitivity in cervical lesions and to bond incremental composite layers. System improves clinical outcomes by ensuring retention of restorative materials and reducing post-operative sensitivity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-component dental adhesive system comprising surface conditioners, primers, and adhesive resin. Chemical-based bonding system. No specific materials standards, connectivity, or software algorithms described.

Indications for Use

Indicated for bonding direct restorative materials (composite resins, compomers, amalgam) and indirect restorative materials (ceramic veneers, inlays, crowns) to enamel and dentin; sealing dentinal tubules; reducing sensitivity in abrasion/erosion lesions; promoting bonding between incremental composite layers; and bonding composite repairs to ceramics and metals. Prescription use only.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• Optibond (K923546)
• All Bond 2 (K910860)
• One Step (K945604)
• Silane Bond Enhancer (896659)

Submission Summary (Full Text)

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K99283Y

# NOV 1 5 1999

5612 Glenwood Road • Bethesda, MD • 20817 • tel [phone] • www.biomatsciences.com

# 510(k) Summary

- BioMat Sciences, Inc. 1. Submitter 5612 Glenwood Road Bethesda, MD 20817 Tel [phone] Fax [phone] Dr. Ivan Stangel (contact person) August 5, 1999 (date of preparation)
- 2. Device Name Trade name - Adhere Common name - Tooth bonding system Classification name - agent, tooth bonding, resin (per CFR 872.3200)
- 3. Legally marketed device for which substantial equivalence is being claimed

Optibond (Kerr, 510k #K923546) All Bond 2 (Bisco, 510k #K910860) One Step (Bisco, 510k #K945604) Silane Bond Enhancer (Pulpdent Corporation 510k #896659)

### 4. Device Description

Adhere is an adhesive system used for the bonding of directly and indirectly placed restorative materials to tooth structure. It consists of surface conditioners, primers, an adhesive resin, initiators and accessories for applying the components to tooth surfaces. After tooth conditioning, a primer is applied, and an adhesive resin overlayer is subsequently placed on the surface to interact with restorative materials. Other primers are used for surface reactions with indirect restorative materials.

#### 5. Intended Use of the Device

Adhere is used to bond restorative materials to enamel and dentin. The materials include composites, compomers, amalgam, ceramic veneers and ceramic inlays. In addition, Adhere is used to seal dentin, and reduce tooth sensitivity in non-bacterial mediated cervical lesions of teeth. Adhere is also used to promote composite bonds to ceramics and metals.

- 6. Technological Characteristics of Present Device Compared to Predicate Device Adhere is substantially equivalent to other legally marketed predicate dental devices. Substantial equivalence is based on performance and the use of components found in other legally marketed tooth bonding agents.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 1999

Mr. Ivan Stangel, D.M.D., F.A.D.M., F.I.C.D. President & Director of Research BioMat Sciences 5612 Glenwood Road Bethesda, MD 20817

K992838 Re : Adhere Conditioner, Adhere Primer, Adhere LC Trade Name: Adhesive, ADH Requlatory Class: II Product Code: KLE Dated: August 15, 1999 August 23, 1999 Received:

Dear Mr. Stangel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Stangel

obligation you might have under sections 531 through 542 of obligation you magne the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberroom in possible equivalence of your device to a legally marketed predicate device results in a classification for your markees probles, 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriance at (30 advertising of your device, please contact the Office of Compliance at [phone]. Also, please note one regulation entitled, "Misbranding by reference to
the regulation entification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 7. Statement of Indications for Use:

- to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns.
- to seal dentinal tubules
- to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth
- to promote bonds between incremental layers of composite resins when building a composite restoration
- to bond composite resins repairs to ceramics and metals

Prescription Usa Usa (Per 21 CFR 801.109)

Supam Runore