Vivasens

FDA 510(k) K030922 · Ivoclar Vivadent, Inc.

Substantially Equivalent

510(k) numberK030922

Submission

Device name
Vivasens
Applicant
Ivoclar Vivadent, Inc.
Amherst, NY, US
Received
March 24, 2003
Decision date
October 17, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LBH – Varnish, Cavity
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3260
Specialty
Dental

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Questions and answers

When was Vivasens cleared by the FDA?

Vivasens (K030922) received a 510(k) decision of Substantially Equivalent on October 17, 2003, 207 days after the submission was received.

What is the product code of K030922?

The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.