← Product Code [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW) · K040053

# PRECISION VPS IMPRESSION MATERIAL (K040053)

_Discus Dental, Inc. · ELW · Mar 25, 2004 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K040053

## Device Facts

- **Applicant:** Discus Dental, Inc.
- **Product Code:** [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW.md)
- **Decision Date:** Mar 25, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3660
- **Device Class:** Class 2
- **Review Panel:** Dental

## Indications for Use

Precision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental impression techniques to reproduce the structure of a patient's teeth and gums.

## Device Story

Precision VPS Impression Material is an addition-reaction polyvinylsiloxane (PVS) dental impression material. Available in three viscosities; used by dental professionals to create accurate physical replicas of patient teeth and gums. Material is applied to dental trays or directly to the oral cavity to capture anatomical structures for crowns, bridges, occlusal, and implant procedures. The material sets in the mouth, creating a negative mold used by dental laboratories to fabricate restorations. Benefits include high-fidelity reproduction of oral structures, facilitating precise fit of dental prosthetics.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Addition-reaction polyvinylsiloxane (PVS) base/catalyst system. Available in three viscosities. Class II medical device (Product Code: ELW).

## Regulatory Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

## Special Controls

*Classification.* Class II (Special Controls).

## Predicate Devices

- Aquasil Ultra Smart Wetting Impression Material ([K021416](/device/K021416.md))
- P2 Polyether ([K030318](/device/K030318.md))

## Submission Summary (Full Text)

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K0400053

## Summary of Safety and Effectiveness B.

Precision VPS Impression Material

- Date of Summary: 1.
- Date of Summary 2. January 8, 2004 Preparation:
- Discus Dental, Inc. 3. Submitting Firm:
- Steven L. Ziemba, M.S. Contact Person 4. Vice-President, Regulatory Affairs Discus Dental, Inc. 8550 Higuera Street Culver City, CA 90232 310.845.8345 310.845.1537 - fax
- Name of Medical Device 5. Precision VPS Impression Material Proprietary Name: Dental Impression Material Common/Usual Name: Classification Name: Impression Material
- Description of Medical Device 6.

Precision VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three different viscosities intended for use with all crowns, bridges, occlusal and dental implant impression procedures.

- 7. Intended Use
Frecision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental impression techniques to reproduce the structure of a patient's teeth and gums.

- Substantial Equivalence Determination 8.
Discus Dental, Inc. believes that the Precision VPS Impression material is substantially equivalent to the following commercially marketed impression materials:

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CONFIDENTIAL

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Predicate Device Aquasil Ultra Smart Wetting Impression Material

Company Dentsply, Intl. 210(k) No K021416

P2 Polyether

Heraeus Kulzer GmbH

K030318

## END OF SUMMARY OF SAFETY AND EFFECTIVENESS

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized, curved shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2004

Mr. Steven L. Ziemba Vice-President, Regulatory Affairs Discus Dental, Incorporated 8550 Higuera Street Culver City California 90232

Re: K040053

Trade/Device Name: Precision VPS Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: January 9, 2004 Received: January 12, 2004

Dear Mr. Ziemba:

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. Ziemba

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 (301) 594-5613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Jung, Ph.D.

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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## Indications for Use Statement E.

**510(k) Number:** K040053

Device Name: Precision VPS Impression material

## Intended Use

Precision VPS Impression Material is intended for use with all crowns, bridges, Precision VFS impression Material is nechniques to reproduce the structure of a patient's teeth and gums.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

|                                                 | Concurrence of CDRH, Office of Device Evaluation (ODE)                                                                             |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Prescription Use<br>Por 21 CFR Section 801.109) | Over-The-Counter Use<br>ાર                                                                                                         |
|                                                 | WYA<br>(Division Sian-Off,<br>Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices<br>510(k) Number: |

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I viscus Dental, Inc.

CONFIDENTIAL

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