EMBRACE DUAL CURE COMPOSITE MATERIALS

K071278 · Pulpdent Corporation · EBF · Jun 29, 2007 · Dental

Device Facts

• Record ID: K071278
• Device Name: EMBRACE DUAL CURE COMPOSITE MATERIALS
• Applicant: Pulpdent Corporation
• Product Code: EBF · Dental
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition. Embrace™ Dual Cure Composite Materials are used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, porcelain/laminate veneers and periodontal splints, to repair porcelain crowns intra-orally and as a build-up and repair material.

Device Story

Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based dental materials; Bisphenol A-free. Used by dental professionals for permanent cementation of restorations (posts, crowns, inlays, onlays, bridges, veneers, splints), intra-oral porcelain repair, and tooth build-up. Material bonds to dentition; dual-cure mechanism allows for polymerization. Benefits include high benefit-to-risk ratio and established safety profile for dental restorative materials.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on comparison to legally marketed predicate devices and historical safety data for dental restorative materials cited from NIH Technology Assessment Conference.

Technological Characteristics

Hydrophilic, fluoride-releasing, resin-based composite material. Dual-cure polymerization mechanism. Bisphenol A-free formulation. Classified as tooth shade resin material under 21 CFR 872.3690.

Indications for Use

Indicated for permanent cementation of dental posts, porcelain crowns, inlays, onlays, bridges, porcelain/laminate veneers, and periodontal splints; intra-oral repair of porcelain crowns; and as a dental build-up and repair material. No specific patient population age or gender restrictions provided.

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™ Resin Cement
• Pulpdent Embrace™ WetBond Pit and Fissure Sealant
• Pulpdent ResiLute Resin Cement
• Pulpdent VLC Resin Cement
• Pulpdent Embrace™ WetBond Restorative Materials
• Apex Dental Materials anchor®
• Den-Mat Core Paste XP

Submission Summary (Full Text)

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# K07127

## EXHIBIT 2

# SUMMARY OF SAFETY AND EFFECTIVENESS DATAJUN 2 9 2007

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

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

#### DEVICE:

Trade Name: PULPDENT EMBRACE™ DUAL CURE COMPOSITE MATERIALS Classification Name: Tooth shade resin material FDA Product Code: 76 EBF. 21 CFR Part 872.3690

#### PREDICATE DEVICES:

Pulpdent Embrace™ Resin Cement Pulpdent Embrace™ WetBond Pit and Fissure Sealant Pulpdent ResiLute Resin Cement Pulpdent VLC Resin Cement Pulpdent Embrace™ WetBond Restorative Materials Apex Dental Materials anchor® Den-Mat Core Paste XP

#### DESCRIPTION AND INTENDED USE:

Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition.

Embrace™ Dual Cure Composite Materials are used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, porcelain/laminate veneers and periodontal splints, to repair porcelain crowns intra-orally and as a build-up and repair material.

#### COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT DUAL CURE COMPOSITE MATERIALS are substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.

#### SAFETY AND EFFECTIVENESS:

PULPDENT DUAL CURE COMPOSITE MATERIALS are 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, 872.3275 and 872.3765.

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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 2 9 2007

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street P.O. Box 780 Watertown, Massachusetts 02472

Re: K071278

Trade/Device Name: Embrace™ Dual Cure Composite Materials Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and EMA Dated: May 02, 2007 Received: May 07, 2007

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Suita y. Michaud.

Chiu S. Lin, PhD 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

510 (k) Number (if known)

0717 28

Device Name

#### PULPDENT EMBRACE™ DUAL CURE COMPOSITE MATERIALS

#### Indications for Use:

Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition.

Embrace™ Dual Cure Composite Materials are used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, porcelain/laminate veneers and periodontal splints, to repair porcelain crowns intra-orally and as a build-up and repair material.

Prescription Use (Part 21 CFR 801 Subpart D)

or

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

540(k) Number

...sion Sign-Off)
Division of Anesthesiology, General Hospital,
..ection Control, Dental Devices

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