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510(k) K231591

V-Print c&b temp by Voco GmbH — Product Code POW

K231591 is an FDA 510(k) premarket notification submitted by Voco GmbH for the device "V-Print c&b temp". The FDA issued a decision of Substantially Equivalent on July 31, 2023. The device falls under product code POW (Crown And Bridge, Long-Term Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Voco GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2023
Date Received
June 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Long-Term Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type

For the fabrication of long-term temporary crowns and bridges

Other clearances by Voco GmbH

  • K252073 — VOCO Profluorid Varnish + BioMin (May 1, 2026)
  • K261357 — Grandio disc multicolor (April 27, 2026)
  • K252606 — Bifix Veneer LC, Bifix Veneer Try-In (March 20, 2026)
  • K251390 — MTA vpt (July 3, 2025)
  • K251239 — GrandioSO Unlimited (May 21, 2025)
  • K231817 — AlignerFlow LC (December 1, 2023)
  • K230877 — Admira Fusion 5 (July 13, 2023)
  • K220236 — V-Print dentbase (September 21, 2022)
  • K220640 — Bifix Hybrid Abutment Cement (August 23, 2022)
  • K220743 — CediTEC (July 5, 2022)

FDA data resources