POLY-CARB

K022030 · Inovativ, LLC · EBG · Aug 28, 2002 · Dental

Device Facts

• Record ID: K022030
• Device Name: POLY-CARB
• Applicant: Inovativ, LLC
• Product Code: EBG · Dental
• Decision Date: Aug 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polycarb is intended for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges using the Inovativ, LLC Polycarb resin.

Device Story

Polycarb is a thermoplastic polycarbonate resin used by dental professionals to fabricate temporary dental prostheses; specifically partial denture clasps, temporary crowns, and bridges. The material is processed via injection molding or pressing equipment. The resulting prostheses are used in a clinical dental setting to provide temporary restoration for patients. The device benefits patients by providing a functional temporary solution during the fabrication of permanent dental work.

Clinical Evidence

No clinical data. Substantial equivalence is based on chemical analysis and comparison of material characteristics and physical properties to the predicate device.

Technological Characteristics

Thermoplastic polycarbonate resin. Used with injection molding or pressing equipment. Material properties, design, and functionality are similar to the predicate device. No specific ASTM standards or software components are described.

Indications for Use

Indicated for patients requiring temporary dental prostheses, including partial denture clasps, temporary crowns, and bridges.

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

• Flexible Dimensions, LLC, temporary crown and bridge resin (Direct Crown)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 2 8 2002

Inovativ Polycarb Original Premarket 510(K) Notification

K022030

### SECTION 9: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR.807.92.

#### 9.1 SUBMITTER INFORMATION

| a. Company Name: | Inovativ, LLC. |
|---------------------------------------------|----------------------------------------------|
| b. Company Address: | 1155 Twin Hills Drive<br>Jefferson, OR 97352 |
| c. Company Telephone:<br>Company Facsimile: | [phone]<br>[phone] |
| d. Contact Person: | Bob Bowers<br>Chief Operating Officer |
| e. Date Summary Prepared: | June 10, 2002 |
| 9.2 DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | Polycarb |

Temporary Crown and Bridge Resin 21 CFR 872.3770

# 9.3 IDENTIFICATION OF PREDICATE DEVICES

The Polycarb material is a thermoplastic resin used to prefabricate partial denture clasps, temporary crowns and bridges. This material is substantially equivalent to the Flexible Dimensions, LLC, temporary crown and bridge resin. This material is commercially available in the United States.

#### 9.4 DEVICE DESCRIPTION

b. Classification Name:

The Polycarb material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.

{1}------------------------------------------------

Inovativ Polycarb Original Premarket 510(K) Notification

#### 9.5 SUBSTANTIAL EQUIVALENCE

The Polycarb thermoplastic polycarbonate resin is substantially equivalent to the Flexible Dimensions, LLC "Direct Crown" polycarbonate resin. The fundamental characteristics are similar: the Polycarb thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device.

## 9.6 INDICATIONS FOR USE

The Polycarb is intended for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges using the Inovativ, LLC Polycarb resin.

## 9.7 TECHNOLOGICAL CHARACTERISTICS

A chemical analysis of the Polycarb is provided within this submission. Both the Polycarb and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 8 2002

Mr. Robert Bowers Chief Operations Officer Inovativ. LLC 1155 Twin Hills Drive Jefferson, Oregon 97352

Re: K022030

Trade/Device Name: Poly-Carb Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: June 10, 2002 Received: June 21, 2002

Dear Mr. Bowers:

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.

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.

{3}------------------------------------------------

Page 2 - Mr. Bowers

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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!

Tim Keller A. Ulatanaki

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number_________________________________________________________________________________________________________________________________________________________________ K022030

Poly-Carb_ Device Name

Indications for use:

The Polycarb is intended for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges using the Inovativ, LLC Polycarb resin.

Do not write below this line - Continue on another page if needed

Prescription Use V (Per 21 CFR 801.109)

OR

Over the counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan Runo

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

510(k) Number: K002030

Page 1 of 1