V-Print c&b temp

FDA 510(k) K231591 · Voco GmbH

Substantially Equivalent

510(k) numberK231591

Submission

Device name
V-Print c&b temp
Applicant
Voco GmbH
Cuxhaven, DE
Received
June 1, 2023
Decision date
July 31, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
POW – Crown And Bridge, Long-Term Temporary, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3770
Specialty
Dental

For the fabrication of long-term temporary crowns and bridges

Other 510(k)s with product code POW

510(k)DeviceApplicantDecision
K261456Ruthinium DiscPOW · Traditional Dental Manufacturing S.p.A.08/05/2026SE

More from Dental Manufacturing S.p.A.

510(k)DeviceDecision
K252073VOCO Profluorid Varnish + BioMinLBH · Traditional 05/01/2026SE
K261357Grandio disc multicolorEBF · Traditional 04/27/2026SE
K252606Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional 03/20/2026SE
K251390MTA vptKIF · Traditional 07/03/2025SE
K251239GrandioSO UnlimitedEBF · Special 05/21/2025SE
K231817AlignerFlow LCDYH · Traditional 12/01/2023SE
K230877Admira Fusion 5EBF · Traditional 07/13/2023SE
K220236V-Print dentbaseEBI · Traditional 09/21/2022SE
K220640Bifix Hybrid Abutment CementEMA · Traditional 08/23/2022SE
K220743CediTECEBI · Traditional 07/05/2022SE

Questions and answers

When was V-Print c&b temp cleared by the FDA?

V-Print c&b temp (K231591) received a 510(k) decision of Substantially Equivalent on July 31, 2023, 60 days after the submission was received.

What is the product code of K231591?

The FDA product code is POW – Crown And Bridge, Long-Term Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.