ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000

K984503 · Wallace A. Erickson & Co. · KLE · Feb 26, 1999 · Dental

Device Facts

• Record ID: K984503
• Device Name: ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
• Applicant: Wallace A. Erickson & Co.
• Product Code: KLE · Dental
• Decision Date: Feb 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Alpha Bond Dentin/Enamel Bonding Agent is a single solution, hydrophilic, unfilled resin that acts both as a moist dentin primer and an adhesive and is primarily used as a Primer/bonding agent between the etched dentin and/or enamel surfaces and the Restorative composite material.

Device Story

Alpha Bond Dentin/Enamel Bonding Agent is a single-solution, hydrophilic, unfilled resin. Used by dental professionals in clinical settings to facilitate adhesion between etched tooth structures (dentin/enamel) and restorative composite materials. Applied directly to prepared tooth surfaces to improve bonding performance of restorative composites. Benefits include simplified application process due to single-solution formulation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Single-solution, hydrophilic, unfilled resin. Designed for dental application as a primer/adhesive. No specific material standards or software components described.

Indications for Use

Indicated for use as a primer and adhesive bonding agent between etched dentin and/or enamel surfaces and restorative composite materials in dental procedures.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1999

Mr. Abner T. de la Cruz Quality Systems Manager and Regulatory Compliance Officer Wallace A. Erickson & Co. 1920 North Clybourn Avenue Chicago, Illinois 60614

Re : K984503 Alpha Bond Dentin/Enamel Bonding Agent, Trade Name: Model 213-000 Requlatory Class: II Product Code: KLE November 30, 1998 Dated: December 18, 1998 Received:

Dear Mr. Cruz

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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulatory 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 obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Cruz

the Act for devices under 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 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 requlation (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 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" (21 CFR 807.97) , Other qeneral 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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## Indications for Use

Alpha Bond Dentin/Enamel Bonding Agent is a single solution, hydrophilic, unfilled resin that acts both as a moist dentin primer and an adhesive and is primarily used as a Primer/bonding agent between the etched dentin and/or enamel surfaces and the Restorative composite material.

Susan Runner

Division Sign-Off) ivision of Dental, Infection Control. and General Hospital Devices 98 510(k) Number

**Prescription Use**
(Per 21 CFR. 301.109)