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510(k) K161630

Provicol QM Plus by Voco GmbH — Product Code EMB

K161630 is an FDA 510(k) premarket notification submitted by Voco GmbH for the device "Provicol QM Plus". The FDA issued a decision of Substantially Equivalent on September 15, 2016. The device falls under product code EMB (Zinc Oxide Eugenol), a Class I device regulated under 21 CFR 872.3275. Voco GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2016
Date Received
June 13, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Zinc Oxide Eugenol
Device Class
Class I
Regulation Number
872.3275
Review Panel
DE
Submission Type

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)
  • K231591 — V-Print c&b temp (July 31, 2023)
  • K230877 — Admira Fusion 5 (July 13, 2023)
  • K220236 — V-Print dentbase (September 21, 2022)
  • K220640 — Bifix Hybrid Abutment Cement (August 23, 2022)

Other clearances for product code EMB

  • K120695 — DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT (June 12, 2012)
  • K110759 — TEMPOCEM (June 10, 2011)
  • K073539 — PROVISA CEM (January 31, 2008)
  • K020158 — NON-EUGENOL TEMPORARY CEMENT (March 7, 2002)
  • K941066 — DENTAL 911 (May 24, 1995)
  • K861681 — DENTIMEDIC DENTAL EMERGENCY KIT (September 23, 1986)
  • K862745 — EUGENOL USP (July 31, 1986)
  • K821581 — DEN TEMP (June 14, 1982)
  • K801779 — OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT (August 7, 1980)
  • K772315 — KWIKAP (January 3, 1978)

FDA data resources