← Product Code [ELW](/productcode/ELW) · K060891

# VIRTUAL (K060891)

_Ivoclar Vivadent, Inc. · ELW · Jul 17, 2006 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K060891

## Device Facts

- **Applicant:** Ivoclar Vivadent, Inc.
- **Product Code:** [ELW](/productcode/ELW.md)
- **Decision Date:** Jul 17, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3660
- **Device Class:** Class 2
- **Review Panel:** Dental

## Indications for Use

Intended to be used for making accurate dental impressions. The resulting impressions are used to make plaster models of the teeth.

## Device Story

Virtual 380 is a dental impression material used by dental professionals to capture accurate anatomical replicas of teeth and oral structures. The material is applied to a dental tray, inserted into the patient's mouth, and allowed to set to form a negative impression. Once cured, the impression is removed and used to create positive plaster models of the patient's dentition. These models serve as diagnostic aids or templates for the fabrication of dental restorations, such as crowns, bridges, or dentures. The device facilitates clinical decision-making by providing a precise physical representation of the patient's oral environment, enabling the dentist to plan and execute restorative treatments with high accuracy.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Impression material (elastomeric). Formulated for dental use to capture oral anatomy. Physical properties consistent with standard dental impression materials (21 CFR 872.3660).

## 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).

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2006

Ms. Donna M. Hartnett Director of QA/Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K060891

Trade/Device Name: Virtual 380 Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: June 22, 2006 Received: June 26, 2006

Dear Ms. Hartnett:

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 - Ms. Hartnett

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ours

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

510(k) Number (if known): K060391

Device Name: VIRTUAL 380

Indications For Use:

Intended to be used for making accurate dental impressions. The resulting impressions are used to make plaster models of the teeth.

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

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)

Page 1 of

Kein Muley San KSR

of Anesthesiology, General Hospital, on Contiol. Dental Devices

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