Vita Suprinity(R)

FDA 510(k) K132070 · Vita Zahnfabrik H.Rauter GmbH & Co.

Substantially Equivalent

510(k) numberK132070

Submission

Device name
Vita Suprinity(R)
Applicant
Vita Zahnfabrik H.Rauter GmbH & Co.
Brea, CA, US
Received
July 3, 2013
Decision date
January 31, 2014
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EIH – Powder, Porcelain
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6660
Specialty
Dental

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Questions and answers

When was Vita Suprinity(R) cleared by the FDA?

Vita Suprinity(R) (K132070) received a 510(k) decision of Substantially Equivalent on January 31, 2014, 212 days after the submission was received.

What is the product code of K132070?

The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.