TEMPORARY CROWN AND BRIDGE MATERIAL

K060293 · Dentsply International, Inc. · EBG · Feb 17, 2006 · Dental

Device Facts

• Record ID: K060293
• Device Name: TEMPORARY CROWN AND BRIDGE MATERIAL
• Applicant: Dentsply International, Inc.
• Product Code: EBG · Dental
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TEMPORARY CROWN AND BRIDGE MATERIAL is indicated for direct fabrication of TEMPORARY CROWN AND BRIDGE veneers, inlays, onlays, crowns or bridges used in indirect restorative procedures.

Device Story

Temporary Crown and Bridge Material is a two-component, methacrylate-based dental resin. It is supplied in an automix delivery system with a 1:1 volume mix ratio. The material is self-curing, initiated by mixing the base and catalyst components. It is intended for use by dental professionals in a clinical setting to fabricate provisional restorations (veneers, inlays, onlays, crowns, bridges) directly for patients undergoing indirect restorative procedures. The device provides a temporary solution for protecting prepared teeth while permanent restorations are being fabricated.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and the use of established dental material components.

Technological Characteristics

Two-component, methacrylate-based, self-curing resin. Automix delivery system (1:1 ratio). Contains stabilizers. All components are established materials used in legally marketed dental devices.

Indications for Use

Indicated for direct fabrication of temporary veneers, inlays, onlays, crowns, or bridges for indirect restorative procedures in dental patients.

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 Automix, K924830

Submission Summary (Full Text)

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FEB 17 2006

K060293

## 510(k) SUMMAR

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|------------------------------------------------------------------|--------------------------------------------|
| DATE PREPARED: | February 2, 2006 |
| TRADE OR PROPRIETARY NAME: TEMPORARY CROWN AND BRIDGE MATERIAL | |
| CLASSIFICATION NAME: | Temporary crown and bridge resin. 872.3770 |
| PREDICATE DEVICES: | Luxatemp Automix, K924830 |

### DEVICE DESCRIPTION:

The TEMPORARY CROWN AND BRIDGE MATERIAL is a two-component, methacrylate-based material. The volume mix of this automixed material is a 1:1 ratio. The unit dose delivery system matchui. "The votential risks associated with asepsis and the need for disinfection.

#### INTENDED USE:

TEMPORARY CROWN AND BRIDGE MATERIAL is indicated for direct fabrication of TEMI ORAN - ONO 177 veneers, inlays, onlays, crowns or bridges used in indirect restorative procedures.

## TECHNOLOGICAL CHARACTERISTICS:

The TEMPORARY CROWN AND BRIDGE MATERIAL is a self-curing, provisional material that is initiated by mixing the catalyst and base. The material is composed of methacrylates, that is intracted of minute stabilizer. And a stabilizer. All of the components found in TEMPORARY CROWN AND BRIDGE MATERIAL have been used in legally marketed I ENI ORIN'T ENO WE's for dental use. We believe that the prior use of the components in devices or were roans bare bate provided, and the biocompatibility data provided legary manced do recor, and effectiveness of TEMPORARY CROWN AND BRIDGE MATERIAL for the indicated uses.

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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 a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

FEB 1 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Mis. Helon Bornb
Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K060293

K000295
Trade/Device Name: Temporary Crown and Bridge Material Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: February 03, 2006 Received: February 06, 2006

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(K) prematically equivalent (for the indications for referenced above and nave decemblicated predicated wices marketed in interstate commerce
use stated in the enclosure) to legally market devices markeers, or to devices that use stated in the enclosure) to legally hianced president of the Amendments, or to devices that prior to May 28, 1976, the elacinent vals of the Miscon of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the PRA ) . You ma have been reclassified in accordance with the premations wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the ge Act (Act) that do not require approval or a promatics apply on of the Act. The general therefore, market the device, subject to mis general sons and registration, listing of devices, good
controls provisions of the Act include requirements for anyisheseding and controls provisions of the Act metade requirements as and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more courtes and consections affecting your device can be
may be subject to such additional controls. Existing major regulations FDA may be subject to such additions, Title 21, Parts 800 to 898 . In addition, FDA may publish found in the Code of I cacral resguinted in the Federal Register.

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## Page 2 - Ms. Helen Lewis

1. Sales and the same

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised mar 1 271 s issualled to but device complies with other requirements of the Act or that FDA nas made a decemination allery sistered by other Federal agencies. You must comply with ally rederal statutes and regulations as and not limited to: registration and listing (21 CFR Part 807); all the ACT s requirements, morading, butacturing practice requirements as set forth in the quality labeling (21 CFR Part 820); and if applicable, the electronic product radiation systems (QD) regallers (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) I his letter wif anow you to ough mating of substantial equivalence of your device to a legally prematics notification. - The PDF 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 If you desire specific acries is your 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general internation on your 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,

Suca Ranses

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):

TEMPORARY CROWN AND BRIDGE MATERIAL -Device Name:

Indications for Use:

TEMPORARY CROWN AND BRIDGE MATERIAL is indicated for direct fabrication of TEMFORANT CROWN THD BRIDGE nlays, crowns or bridges used in indirect restorative procedures.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

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