EMBRACE WET-BOND RESTORATIVE MATERIAL

K031877 · Pulpdent Corporation · EBF · Aug 1, 2003 · Dental

Device Facts

• Record ID: K031877
• Device Name: EMBRACE WET-BOND RESTORATIVE MATERIAL
• Applicant: Pulpdent Corporation
• Product Code: EBF · Dental
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Embrace™ Wet-Bond Restorative Material is a hydrophilic, fluoride-releasing, light-cured material recommended for use as a tooth replacement material. Applications of Embrace™ Wet-Bond Restorative Material include: Class I, III, IV, and V cavity preparations and as a restorative material for small incipient lesions.

Device Story

Embrace™ Wet-Bond Restorative Material is a hydrophilic, fluoride-releasing, light-cured dental restorative material. Used by dentists in clinical settings for filling Class I, III, IV, and V cavity preparations and small incipient lesions. Material applied directly to tooth structure; light-cured to harden. Provides tooth replacement functionality; fluoride release intended for restorative benefit. Clinical decision-making based on standard dental restorative protocols.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by laboratory testing comparing physical and mechanical properties to predicate devices and reliance on established safety profiles of similar dental restorative materials.

Technological Characteristics

Hydrophilic, fluoride-releasing, light-cured resin-based restorative material. Class II dental device (21 CFR 872.3690).

Indications for Use

Indicated for patients requiring tooth replacement material for Class I, III, IV, and V cavity preparations and small incipient lesions.

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 Embrace™ Pit and Fissure Sealant
• Ivoclar Tetric Flow
• Ivoclar Compoqlass Flow
• Kuraray Clear-Fil
• Kerr OptiBond Solo Plus 3

Submission Summary (Full Text)

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K031877

### EXHIBIT 2

## SUMMARY OF SAFETY AND EFFECTIVENESS DATA AUG - 1 2003

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

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

#### Embrace™ Wet-Bond Restorative Material DEVICE NAME:

#### PREDICATE DEVICES:

Pulpdent Embrace™ Pit and Fissure Sealant Ivoclar Tetric Flow Ivoclar Compoqlass Flow Kuraray Clear-Fil Kerr OptiBond Solo Plus 3

#### DESCRIPTION AND INTENDED USE:

Embrace™ Wet-Bond Restorative Material is a hydrophilic, fluoride-releasing, light-cured material recommended for use as a tooth replacement material. Applications of Embrace™ Wet-Bond Restorative Material include: Class I, III, IV, and V cavity preparations and as a restorative material for small incipient lesions.

#### COMPARISON WITH PREDICATE PRODUCTS:

Embrace™ Wet-Bond Restorative Material is substantially equivalent in design, composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.

#### SAFETY AND EFFECTIVENESS:

Pulpdent Embrace™ Wet-Bond Restorative Material 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, 872.3765 or 872.3200. The chemical
ingredients used in Embrace™ Wet-Bond Restorative Material are used in the predicate Though there is no ISO or ANSI/ADA standard applicable to Embrace" Wet-Bond Restorative
Material, laboratory testing has shown that Embrace" Wet-Bond Restorative Material is 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 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.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

AUG - 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031877

Trade/Device Name: Embrace™ Wet-Bond Restorative Material Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 13, 2003 Received: June 24, 2003

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), 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) you may obtain. 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,

Patrici Ciccentiffo

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

K031877

510 (k) Number (if known)

Device Name

Pulpdent Embrace™ Wet-Bond Restorative Material

Indications for Use:

Embrace™ Wet-Bond Restorative Material is a hydrophilic, fluoride-releasing, light-cured material recommended for use as a tooth replacement material. Applications of Embrace™ Wet-Bond Restorative Material include: Class I, III, IV, and V cavity preparations and as a restorative material for small incipient lesions.

Kein Muly for WSR

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K031879

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

or

Over-The-Counter Use