PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT

K014138 · Pulpdent Corp. · DYH · Mar 14, 2002 · Dental

Device Facts

• Record ID: K014138
• Device Name: PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
• 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 Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the advantages of glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ is a fluoride releasing, light-cure, self-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching gel to adhere orthodontic brackets to tooth surfaces

Device Story

Pulpdent Triple-Cure is a multi-purpose orthodontic cement supplied as a powder and liquid. It functions as a bracket adhesive and band cement, combining glass ionomer properties with dental resin technology. The material is fluoride-releasing and utilizes both light-cure and self-cure mechanisms. It is applied by a dental professional in a clinical setting, typically following enamel etching with a gel. The cement adheres orthodontic brackets or bands to tooth surfaces, facilitating orthodontic treatment. The device provides mechanical fixation for orthodontic appliances.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by reference to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, citing a high benefit-to-risk ratio and extensive historical usage of similar materials.

Technological Characteristics

Multi-purpose orthodontic cement; powder and liquid form; glass ionomer and dental resin composition; fluoride-releasing; light-cure and self-cure polymerization mechanisms; used with enamel etching gel.

Indications for Use

Indicated for use as a multi-purpose orthodontic cement for bonding orthodontic brackets and cementing bands to tooth 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.

Predicate Devices

• GC Fuji Ortho LC (light-cure)
• GC Fuji Ortho Self-cure
• Pulpdent Band-Rite

Submission Summary (Full Text)

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PULPDENT CORPORATION

K014138

510 k Premarket Notification

Pulpdent Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement

# MAR 1 4 2002

## EXHIBIT 2

## 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 Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement Classification Name: Adhesive, Bracket and Tooth Conditioner, Resin FDA Product Code: DYH, 21 CFR Part 872.3750

#### PREDICATE DEVICES

GC Fuji Ortho LC (light-cure) GC Fuii Ortho Self-cure Pulpdent Band-Rite

#### DESCRIPTION AND INTENDED USE

PULPDENT Triple-Cure™ Reinforced Glass lonomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the of thouonic cement that ban be dood as a bracked as a brache of early of the edire" ("" (" is a fluoride releasing, light-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching gel to adhere orthodontic brackets to tooth surfaces.

## COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT Triple Cure Orthodontic Bracket Adhesive is substantially equivalent in composition and intended use to the predicate products 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 benefitto-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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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: K014138

Trade/Device Name: Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Regulation Number: 872.3750 Regulation Name: Adhesive, Bracket and Tooth Conditioner, Resin Regulatory Class: II Product Code: DYH Dated: December 13, 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 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.

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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 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 STATEMENT

K014138

510 (k) Number (if known)

## Device Name: PULPDENT Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement

## Indications for Use:

PULPDENT Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the advantages of glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ is a fluoride releasing, light-cure, self-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching 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)

Over-The-Counter Use

(Division Sign-Off) Chelsion of Dental, Infection Control, and General Hospital Devices 610(k) Number ----------------------------------------------------------------------------------------------------------------------------------------------------------------