Provicol QM Plus— 510(k) K161630

Clearance details

Applicant

Voco GmbH

Product code

Code EMB

Device class

Class 1

Regulation

21 CFR 872.3275

Advisory panel

Dental

Date received

2016-06-13

Decision date

2016-09-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cuxhaven, DE

• K120695 — DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT2012-06-12
• K110759 — TEMPOCEM2011-06-10
• K073539 — PROVISA CEM2008-01-31
• K020158 — NON-EUGENOL TEMPORARY CEMENT2002-03-07
• K941066 — DENTAL 9111995-05-24

• K252073 — VOCO Profluorid Varnish + BioMin2026-05-01
• K261357 — Grandio disc multicolor2026-04-27
• K252606 — Bifix Veneer LC, Bifix Veneer Try-In2026-03-20
• K251390 — MTA vpt2025-07-03
• K251239 — GrandioSO Unlimited2025-05-21