TEMPORARY CROWN & BRIDGE RESIN

K060881 · Cosmedent, Inc. · EBG · May 16, 2006 · Dental

Device Facts

• Record ID: K060881
• Device Name: TEMPORARY CROWN & BRIDGE RESIN
• Applicant: Cosmedent, Inc.
• Product Code: EBG · Dental
• Decision Date: May 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.

Device Story

Cosmedent Temporary Crown and Bridge Resin is a self-cure composite resin composed of difunctional acrylic monomers and silicaceous fillers. Used by dental professionals in clinical settings to fabricate temporary crown, bridge, inlay, and onlay restorations. Supplied as an auto-mix system; preloaded syringes are dispensed via hand-gun. Material is either loaded into an impression tray for placement in the patient's mouth or applied directly to the prepared tooth. The resin cures in situ to provide temporary coverage for up to 90 days, mimicking natural tooth appearance. The device is radiopaque to assist in clinical assessment. It serves as a temporary restorative solution, protecting prepared teeth while permanent restorations are fabricated.

Clinical Evidence

Bench testing only. Comparative physical and mechanical property data provided, including compressive strength (225 MPa vs 220 MPa), flexural strength (82 MPa vs 92 MPa), and filler content (46% vs 44%).

Technological Characteristics

Self-cure composite resin; composition: difunctional acrylic monomers and silicaceous fillers. Supplied as auto-mix system for hand-gun dispensing. Radiopaque. Physical properties: 225 MPa compressive strength, 82 MPa flexural strength, 46% filler by weight.

Indications for Use

Indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations in patients requiring temporary dental coverage.

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

Submission Summary (Full Text)

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Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for Temporary CROWN AND BRIDGE Resin Page 16 of 17

## 510(k) SUMMARY

As required by the Safe Medical Devices Act of 1990

### DESCRIPTION OF THE APPLICANT DEVICE

MAY 16 7000

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TRADE NAME: Multiple

COMMON NAME: Temporary Crown and Bridge Resin

CLASSIFICATION NAME: Temporary Crown and Bridge Resin (21 CFR 872.3770, Product code EBG)

Cosmedent TEMPORARY CROWN AND BRIDGE RESIN is a self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials have sufficient physical properties to function in the oral cavity for up to 90 days and have esthetic qualities that mimic natural tooth appearance.

The technological characteristics of the applicant device are essentially identical to the predicate device.

# IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

TRADE NAME: Luxatemp COMMON NAME: Temporary Crown and Bridge Resin CLASSIFICATION NAME: Temporary Crown and Bridge Resin (21 CFR 872.3770, Product code EBG)

| | Cosmedent | LUXATEMP |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| EQUIVALENTS | TEMPORARY C & B Filling<br>Material | Temporary<br>Filling Material |
| | Similarities | |
| Intended Use | Both products have identical intended uses as temporary crown and<br>bridge filling materials | |
| Composition | Both products have substantially the same chemical composition.<br>They are self-cure, silica filled, difunctional acrylic composites | |
| Physical properties | Both products have similar physical and mechanical properties as<br>shown in Table I below | |
| How supplied and used | Both products are supplied as auto-mix systems. Preloaded syringes<br>are mixed and dispensed in a hand-gun and the mixed material is<br>either loaded into an impression and placed in the patient's mouth or<br>the product is applied directly on the prepared tooth. | |
| Mechanical and Physical Properties | Cosmedent<br>TEMPORARY C & B Filling<br>Material | LUXATEMP<br>Temporary<br>Filling Material |
| Compressive strength | 225 MPa | 220 MPa |
| Flexural strength | 82 MPa | 92 MPa |
| Percent filler by weight | 46 | 44 |
| Radiopaque | Yes | Yes |
| | Differences | |
| Attachment pickup use | No | Yes |

## SUBSTANTIAL EQUIVALENCE SUMMARY

Submitted by: James L. Sandrik, PhD Cosmedent, Inc. 401 N. Michigan Ave. Suite 2500 Chicago, IL 60611

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 16 2005

James L. Sandrik, PhD Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611

Re: K060881

Trade/Device Name: Temporary Crown and Bridge Resin Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: March 29, 2006 Received: March 31, 2006

Dear Dr. Sandrik:

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 Eederal Register.

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## Page 2 - James L. Sandrik, PhD

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 Part 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,

itte of Michael Oma

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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Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for Temporary CROWN AND BRIDGE Resin

Page 5 of 17

# INDICATIONS FOR USE

510(k) Number (if known):

K060661

Device Name: MULTIPLE (TEMPORARY CROWN AND BRIDGE RESIN )

Indications For Use:

Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.

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

1 : - ( : ) Tot Anonihesiology, General Hospital, on Control, Cantal Devices

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