DENTITION INTEGRATING MATERIAL

K020287 · Pulpdent Corporation · EBC · Apr 12, 2002 · Dental

Device Facts

• Record ID: K020287
• Device Name: DENTITION INTEGRATING MATERIAL
• Applicant: Pulpdent Corporation
• Product Code: EBC · Dental
• Decision Date: Apr 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pulpdent Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.

Device Story

Pulpdent Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based dental material. It is applied by dental professionals to the pits and fissures of teeth to provide a protective seal. The material bonds to the tooth structure upon light curing. It is used in a clinical dental setting to manage dental health by preventing caries. The device benefits patients by providing a physical barrier against decay-causing bacteria and releasing fluoride.

Clinical Evidence

Bench testing only. Laboratory testing demonstrated that the physical and mechanical properties of the material are equivalent to the predicate products. No clinical trials were conducted; reliance is placed on the established safety and effectiveness of similar dental materials used in millions of procedures.

Technological Characteristics

Fluoride-releasing, light-cured, resin-based dental material. Formulated for bonding to tooth structure. No specific ASTM standards or software components described.

Indications for Use

Indicated for filling and sealing pits and fissures in teeth to prevent dental caries. Suitable for use in patients requiring dental sealant application.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Predicate Devices

• Pulpdent Flows-Rite
• Pulpdent Seal-Rite Pit and Fissure Sealant
• Pulpdent Seal-Rite Low Viscosity Pit and Fissure Sealant
• Pulodent Seal-Rite UDMA
• Kuraray Clear-Fil
• Kerr OptiBond Solo Plus 3

Submission Summary (Full Text)

{0}------------------------------------------------

## APR 1 2 2002

PULPDENT CORPORATION

510 k Promarket Notification K 020287 Pulpdent Dentition Integrating Material

#### EXHIBIT 2

### SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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

Telephone: [phone] Fax: [phone] [e-mail]

#### DEVICE:

Trade Name: PULPDENT DENTITION INTEGRATING MATERIAL Classification Name: Sealant, Pit and Fissure, and Conditioner FDA Product Code: 76 EBC, 21 CFR Part 872.3765

#### PREDICATE DEVICE:

Pulpdent Flows-Rite Pulpdent Seal-Rite Pit and Fissure Sealant Pulpdent Seal-Rite Low Viscosity Pit and Fissure Sealant Pulodent Seal-Rite UDMA Kuraray Clear-Fil Kerr OptiBond Solo Plus 3

#### DESCRIPTION AND INTENDED USE:

Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.

## COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT DENTITION INTEGRATING MATERIAL Is substantially equivalent in design, composition, r of DENT DENTITUTY in a safety and effectiveness to the predicate products listed above.

### SAFETY AND EFFECTIVENESS:

PULPDENT DENTITION INTEGRATING MATERIAL is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above . The periormance, intended bost, but strantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3690, 872.3765 or 872.3200. The chemical process as Class II Dentifican Integrating Material are used in the predicate products. Though there is no Ingledients dsed in Demittion Integraing Material, laboratory testing Material, laboratory testing has shown that Dentifian Integrating Material is equivalent in physical and mechanical properties to the predicale products.

According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dential Accurative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk rationals. " Ocheral assge of these are relatively trouble free. There is no evidence of shorthis fratu... Dour composites and grass londiners are relatively billions of procedures in the United States.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2002

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

Re: K020287

Trade/Device Name: Pulpdent Dentition Integrating Material Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: January 23, 2002 Received: January 28, 2002

Dear Mr. Berk:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave 10 row and have determined the device is substantially equivalent (for the recenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to hay are 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 approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 If your device is classified (see a siditional controls. Existing major regulations affecting (I MA), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish 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 mount that I Dr may Federal statutes and regulations administered by other Federal agencies.

{2}------------------------------------------------

### Page 2 - Mr. Berk

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

{3}------------------------------------------------

K.020.28"

Page 1 of 1

# INDICATIONS FOR USE STATEMENT

K 020287 510 (k) Number

#### PULPDENT DENTITION INTEGRATING MATERIAL Device Name

Indications for Use:

Pulpdent Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.

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

Susan Runo

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