PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE

K014133 · Pulpdent Corp. · DYH · Mar 14, 2002 · Dental

Device Facts

• Record ID: K014133
• Device Name: PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
• Applicant: Pulpdent Corp.
• Product Code: DYH · Dental
• Decision Date: Mar 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended Use

Pulpdent No-Mix Orthodontic Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

Device Story

Pulpdent No-Mix Orthodontic Bracket Adhesive is a fluoride-releasing, self-cure resin adhesive system. Used by dental professionals in clinical settings to bond orthodontic brackets to enamel. System components include the adhesive, a liquid primer, and a 38% phosphoric acid etching gel. The clinician applies the etching gel to the tooth surface, followed by the primer, and then uses the adhesive to secure the bracket. The self-cure mechanism eliminates the need for external light curing. The device facilitates orthodontic treatment by providing a stable bond between the bracket and the tooth.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by literature regarding the general usage of similar dental restorative materials (composites and glass ionomers) over approximately 20 years, indicating a high benefit-to-risk ratio.

Technological Characteristics

Fluoride-releasing, self-cure resin adhesive system. Components include a liquid primer and 38% phosphoric acid etching gel. Classified as a Class II Dental Device under 21 CFR 872.3750.

Indications for Use

Indicated for use by dental professionals to adhere orthodontic brackets to tooth surfaces using a self-cure adhesive system, liquid primer, and 38% phosphoric acid etching gel.

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.

Predicate Devices

• GAC OrthoLoc
• GAC One-Step
• Reliance Rely-a-Bond No Mix Orthodontic Adhesive
• Reliance Rely-a-Bond w/Fluoride No Mix Adhesive

Submission Summary (Full Text)

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2,2

510 k Premarket Notification

Pulpdent No-Mix Orthodontic Bracket Adhesive

# EXHIBIT 2

MAR 1 4 2002

# SUMMARY OF SAFETY AND EFFECTIVENESS DATA

## RESPONSE TO SMDA OF 1990

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: Fax:

617-926-6666 617-926-6262

### DEVICE:

Trade Name: PULPDENT No-Mix Orthodontic Bracket Adhesive Classification Name: Adhesive, Bracket and Tooth Conditioner, Resin FDA Product Code: DYH. Part 872.3750

#### PREDICATE DEVICES:

GAC OrthoLoc GAC One-Step Reliance Rely-a-Bond No Mix Orthodontic Adhesive Reliance Rely-a-Bond w/Fluoride No Mix Adhesive

## DESCRIPTION AND INTENDED USE:

PULPDENT No-Mix Orthodontic Bracket Adhesive is a fluoride-releasing, self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

## COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT No Mix Orthodontic Adhesive is substantially equivalent in composition and intended use to the predicate product listed above. Please see Exhibit 4 for the entire comparison.

#### SAFETY AND EFFECTIVENESS:

According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States. In addition, the predicate products listed above have been given 510 (k) premarket approval as Class II Dental Devices under CFR 872.3750.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure or bird-like shape, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2002

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472

Re: K014133

Trade/Device Name: Pulpdent No-Mix Orthodontic Bracket Adhesive Regulation Number: 872.3750 Regulation Name: Adhesive, Bracket and Tooth Conditioner, Resin Regulatory Class: II Product Code: DYH Dated: December 11, 2001 Received: December 17, 2001

Dear Mr. Berk:

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 (2012) 1) 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.

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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 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

Timothy A 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 STATEMENT

KO14133

510 (k) Number (if known)

PULPDENT NO MIX ORTHODONTIC BRACKET ADHESIVE Device Name

## Indications for Use:

Pulpdent No-Mix Orthodontic Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | | |
|----------------------|----------------------------------------|----------------------|
| (Per 21 CFR 801.109) | or | Over-The-Counter Use |
| | (Division Sign-Off) | |
| | Division of Dental, Infection Control, | |
| | and General Hospital Devices | |
| | K014133 | |

F 1 (k) Number _

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