PRO-V

K073263 · Bisco, Inc. · EBG · Feb 14, 2008 · Dental

Device Facts

• Record ID: K073263
• Device Name: PRO-V
• Applicant: Bisco, Inc.
• Product Code: EBG · Dental
• Decision Date: Feb 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PRO-V is line of provisional restorative materials designed to address the differing requirements for creating or placing any provisional restoration. The PRO-V System consists of PRO-V FLO, PRO-V FILL, and PRO-V COAT which offers a complete solution to create an effective inlay or onlay provisional.

Device Story

PRO-V is a dental restorative system comprising PRO-V FLO (flowable composite), PRO-V FILL (packable composite), and PRO-V COAT (separating agent). Used by dental professionals for temporary inlay and onlay restorations. PRO-V COAT is applied to adhesive-coated tooth surfaces to create a barrier; PRO-V FLO or FILL is then placed and light-cured. The system allows for easy removal of the provisional material when no longer needed, with the separating agent rinsed away with water. Benefits include simplified temporization and protection of the underlying tooth structure during the interim period before permanent restoration.

Clinical Evidence

No clinical data provided. Biocompatibility testing was performed to confirm safety.

Technological Characteristics

Light-cured, glass-filled, resin-based dental composite system. Includes low-viscosity (FLO) and high-viscosity (FILL) variants and a water-soluble separating agent (COAT).

Indications for Use

Indicated for temporary fillings, provisional inlays, and provisional onlays in patients requiring temporary dental restorations.

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

• E-Z Temp (K92432)

Submission Summary (Full Text)

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Ko73263

Page 5-1

FEB 1 4 2008

# Section 5 510 (k) SUMMARY

Applicant: Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 Contact Person: Benjamin Lichtenwalner Tel: [phone] Fax: [phone] November 19, 2007 Date Prepared: PRO-V Trade Name: Temporary/Provisional Filling Material Common Name:

Dental Cement

## Description of Applicant Device:

Classification/Name:

PRO-V is line of provisional restorative materials designed to address the differing requirements for creating or placing any provisional restoration. The PMO-V System consists of PRO-V FLO, PRO-V FII.1, and PRO-V COAT. PRO-V FLO™ is a flowable composite for use as a provisional for inlay restorations. PRO-V FILL™ is a packable composit: for use as a provisional for onlay restorations. PRO-V COATTM is a separating agent.

Class II per 21 CFR 872.3275

### Intended uses of Applicant Device:

The PRO-V COAT is easily applied to an adhesive coated tooth surface before temporization with PRO-V FI.O or PRO-V FILL for provisional inlay or onlay cestorations. The PRO-V COAT provides a barrier between the applied adhesive resin and provisional fi ling materials. The PRO-V FLO or PRO-V FILL can then be easily removed when no longer needed and the PRO-V COAT is simply rinsed off with copious amounts of water.

Predicate Devices: E-Z Temp cleared under (K924) 32) dated July 8, 1993.

#### Significant Performance Characteristics:

| | E-Z Temp | PRO-V |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Provisional Inlay and Onlay Restorative | Provisional Inlay and Onlay Restorative |
| Chemical<br>composite | Light-cured, glass filled, resin based inlay<br>and onlay composite supplied with a water-<br>soluble separating agent | Light-cured, glass filled, resin based<br>inlay and onlay composite supplied with<br>a water-soluble separating agent |
| Mechanical /<br>Physical<br>properties | E-Z Temp Inlay: Low viscosity<br>dispensable composite<br>E-Z Temp Onlay: High viscosity<br>sculptable composite<br>E-Z Temp Separating Agent: Water-<br>soluble separating agent | PRO-V FLO: Low viscosity,<br>dispensable composite<br>PRO-V FILL: High viscosity sculptable<br>composite<br>PRO-V COAT: Water-soluble<br>separating agent |

### SUBSTANTIAL EQUIVALENCE SUMMARY

Side by side comparisons of PRO-V to the predicate device E-Z Temp clearly demonstrates that the applicant device is substantially equivalent to the legally marked device. PRO-V was tested for hiocompatibility and it was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of PINO-V.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Benjamin Lichtenwalner Regulatory Affairs Manager Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K073263

Trade/Device Name: PRO-V Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: November 19, 2007 Received: November 20, 2007

Dear Mr. Benjamin Lichtenwalner:

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. Benjamin Lichtenwalner

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" (21CFR 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.

Supt. y. Michael Davis.

Chiu Lin, Ph.D. 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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510 (k) Number (if known):

K073263

Device Name: PRO-V

Indications for Use Statement:

PRO-V is line of provisional restorative materials designed to address the differing I KV-V is fine of provisional restorational restoration. The PRO-V System requirements for creating of practing u.J., and PRO-V COAT which offers a complete solution to create an effective inlay or onlay provisional.

Indications for Use:

- Temporary fillings A.
- Provisional Inlays B.
- Provisional Onlays (.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/CIR

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)

Suen Runn

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Ancola Dental Devices

510(k) Number: **__**