PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

K012673 · Prime Dental Manufacturing, Inc. · DYH · Oct 24, 2001 · Dental

Device Facts

• Record ID: K012673
• Device Name: PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
• Applicant: Prime Dental Manufacturing, Inc.
• Product Code: DYH · Dental
• Decision Date: Oct 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prime-Dent® One-Step Orthodontic Adhesive Bonding System is a resin/paste for bonding any orthodontic bracket to any enamel surface that has been properly conditioned. An active archwire may be placed immediately after adhesive has properly cured.

Device Story

Prime-Dent One-Step Orthodontic Adhesive Bonding System is a resin/paste adhesive used by dental professionals to bond orthodontic brackets to enamel. The system requires prior conditioning of the tooth surface. Once applied and cured, the adhesive secures the bracket, allowing for immediate placement of an active archwire. The device is used in a clinical dental setting to facilitate orthodontic tooth movement.

Clinical Evidence

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

Technological Characteristics

Resin/paste orthodontic adhesive system. Class II device (21 CFR 872.3750). Product code: DYH.

Indications for Use

Indicated for bonding orthodontic brackets to conditioned enamel surfaces in patients requiring orthodontic treatment.

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2001

Mr. Rolando Marasigan Vice President of Manufacturing Prime Dental Manufacturing, Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618

Re: K012673

Trade/Device Name: Prime-Dent One-Step Orthodontic Adhesive Bonding System Regulation Number: 21 CFR 872.3750 Regulation Name: Adhesive, Bracket and Tooth Conditioner, Resin Regulatory Class: Class II Product Code: DYH Dated: August 3, 2001 Received: August 14, 2001

Dear Mr. Marasigan:

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.

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

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Page 2 - Mr. Marasigan

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 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,

[signature]

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

Prime-Dent® One-Step Orthodontic Adhesive Bonding System is a resin/paste Frine-Demer One-Diep Orthodonal Prairer ve bracket bonded to any ordiodontic backer oomains of exemply conditioned. An active archwire may be placed immediately after adhesive has properly cured.

Susan Roper

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Kin 267