PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL

K081810 · Pulpdent Corporation · EBG · Sep 17, 2008 · Dental

Device Facts

• Record ID: K081810
• Device Name: PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL
• Applicant: Pulpdent Corporation
• Product Code: EBG · Dental
• Decision Date: Sep 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pulpdent Temporary Crown and Bridge Material is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.

Device Story

Pulpdent Temporary Crown and Bridge Material is a dual-cure, glass-filled resin composite. Used by dental professionals in clinical settings to fabricate temporary crowns and bridges. Material serves as an interim restoration until permanent prosthesis is ready. Device relies on established dental material chemistry; no complex electronics or software involved.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on comparison to legally marketed predicate devices and historical safety data of similar dental restorative materials.

Technological Characteristics

Dual-cure, glass-filled resin composite. Formulated from materials with established history in dental industry. No electronic components, software, or connectivity features.

Indications for Use

Indicated for dental professionals to fabricate temporary prostheses, such as crowns or bridges, for patients requiring interim restorations until a permanent restoration is completed.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• Luxatemp
• DMG Luxatemp Solar
• DMG Sci-Span
• Scientific Pharmaceuticals Inc. Integrity
• Dentsply International CosmeTemp
• Cosmedent Inc.

Submission Summary (Full Text)

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K081810

PULPDENT CORPORATION

## SEP 1 7 2008

510 k Premarket Notification Pulpdent Temporary Crown and Bridge Material

#### EXHIBIT 2

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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 Temporary Crown and Bridge Material Classification Name: Temporary Crown and Bridge Resin Class: Il FDA Product Code: 76 EBG, 21 CFR Part 872.3770

#### PREDICATE DEVICES:

Luxatemp, DMG Luxatemp Solar, DMG Sci-Span, Scientific Pharmaceuticals Inc. Integrity, Dentsply International CosmeTemp, Cosmedent Inc.

#### DESCRIPTION AND INTENDED USE:

Pulpdent Temporary Crown and Bridge Material is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.

#### COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent Temporary Crown and Bridge 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 872.3770.

#### SAFETY AND EFFECTIVENESS:

Pulpdent Temporary Crown and Bridge Material is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above that have been on the market and used by dental professionals for more than 15 years with no serious safety or effectiveness problems. Pulpdent Temporary Crown and Bridge Material is fabricated from materials that have been used in the dental industry for many years.

According to the NIN 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 seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081810

Trade/Device Name: Pulpdent Temporary Crown and Bridge Material Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: June 18, 2008 Received: June 26, 2008

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. 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 complics 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Thlmnuels-fleury for 11

Chiu S. Lin. Ph. D Division 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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# 081810

### INDICATIONS FOR USE

510 (k) Number (if known)

Device Name:

PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL

Indications for Use:

Pulpdent Temporary Crown and Bridge Material is used by the dental professional to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Prescription Use X

or

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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 Dunn

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

510(k) Number:

1