Vita Enamic Stains

FDA 510(k) K123761 · Innovation Meditech GmbH

Substantially Equivalent

510(k) numberK123761

Submission

Device name
Vita Enamic Stains
Applicant
Innovation Meditech GmbH
Brea, CA, US
Received
December 7, 2012
Decision date
March 1, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBD – Coating, Filling Material, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3310
Specialty
Dental

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Questions and answers

When was Vita Enamic Stains cleared by the FDA?

Vita Enamic Stains (K123761) received a 510(k) decision of Substantially Equivalent on March 1, 2013, 84 days after the submission was received.

What is the product code of K123761?

The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.