PULPDENT GLAZE

K020432 · Pulpdent Corporation · EBF · Apr 17, 2002 · Dental

Device Facts

• Record ID: K020432
• Device Name: PULPDENT GLAZE
• Applicant: Pulpdent Corporation
• Product Code: EBF · Dental
• Decision Date: Apr 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze is offerent formulations to meet the needs of the dental professional: filled, unfilled, very low filler level, no fluoride and fluoridereleasing. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.

Device Story

Pulpdent Glaze is a light-cured resin material used by dental professionals in clinical settings. It is applied to enamel and composite restorations to seal surfaces, margins, and cracks, and to reduce micro-leakage; specific formulations are used for dentin bonding. The device functions as a protective coating or bonding agent. It is applied manually by the clinician and cured using a dental light source. The output is a cured resin layer that improves the integrity of dental restorations and reduces potential for leakage, benefiting the patient by extending the life of restorations and protecting tooth structure.

Clinical Evidence

Bench testing only. Laboratory testing demonstrated that physical and mechanical properties are equivalent to predicate devices. No clinical trials were conducted; reliance was placed on the established safety profile of similar dental restorative materials as documented in NIH Technology Assessment Conference reports.

Technological Characteristics

Light-cured resin material; available in filled, unfilled, and low-filler formulations; some versions are fluoride-releasing. Bisphenol A-free. Applied via manual dental instrumentation and cured with a dental light source.

Indications for Use

Indicated for dental professionals to seal composite surfaces, restoration margins, and cracks in teeth/restorations, and to reduce micro-leakage. Two formulations are indicated for dentin bonding.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Pulpdent DenTASTIC UNO
• Pulpdent Flows-Rite
• UltraDent PermaSeal
• UltraDent PermaQuick
• Bisco Fortify
• Kuraray Clear-Fil SE Bond
• Kerr Opti Bond Solo Plus 3

Submission Summary (Full Text)

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# APR 1 7 2002

510 k Premarket Notification Pulpdent Glaze

## EXHIBIT 2

K020432

#### SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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

617-926-6666 Telephone: [phone] Fax: [e-mail]

#### DEVICE:

Trade Name: PULPDENT GLAZE Classification Name: Tooth Shade Resin Material FDA Product Code: 76 EBF, 21 CFR Part 872.3690

#### PREDICATE DEVICES:

Pulpdent DenTASTIC UNO Pulpdent Flows-Rite UltraDent PermaSeal UltraDent PermaQuick Bisco Fortify Kuraray Clear-Fil SE Bond Kerr Opti Bond Solo Plus 3

#### DESCRIPTION AND INTENDED USE:

Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze is offered in different formulations to meet the dental professional: filled, unfilled, very low filler level, no fluoride-releasing. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.

#### COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT GLAZE substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.

#### SAFETY AND EFFECTIVENESS:

PULPDENT GLAZE is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3690 or 872.3200. The chemical ingredients used in Pulpdent Glaze are used in two of the predicate products. Though there is no ISO or ANSI/ADA standard applicable to Pulpdent Glaze, laboratory testing has shown that Pulpdent Glaze is equivalent in physical and mechanical properties to the predicate products.

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-torisk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of shortterm or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape and features the department's emblem in the center. The emblem consists of three stylized human profiles facing to the right, with a bird-like shape above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2002

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

Re: K020432

Trade/Device Name: Pulpdent Glaze Regulation Number: 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Codes: EBD, EBF, and KLE Dated: February 01, 2002 Received: February 08, 2002

## 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.

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## Page 2 - Mr. Kenneth J. Berk

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

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# INDICATIONS FOR USE STATEMENT

190127 -

510 (k) Number (if known)

PULPDENT GLAZE Device Name

### Indications for Use:

Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze is offerent formulations to meet the needs of the dental professional: filled, unfilled, very low filler level, no fluoride and fluoridereleasing. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per 21 CFR 801.109)

or

Over-The-Counter Use

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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number _

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