Virtual

FDA 510(k) K060891 · Ivoclar Vivadent, Inc.

Substantially Equivalent

510(k) numberK060891

Submission

Device name
Virtual
Applicant
Ivoclar Vivadent, Inc.
Amherst, NY, US
Received
March 31, 2006
Decision date
July 17, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ELW – Material, Impression
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3660
Specialty
Dental

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Questions and answers

When was Virtual cleared by the FDA?

Virtual (K060891) received a 510(k) decision of Substantially Equivalent on July 17, 2006, 108 days after the submission was received.

What is the product code of K060891?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.