510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K061823Substantially Equivalent

Admira Protect/admira Protect Single Dose

Voco GmbH, Cuxhaven, DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K061823 is the FDA 510(k) clearance record for ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE, a class II device, cleared for Voco GmbH on under FDA product code EBC (Sealant, Pit And Fissure, And Conditioner). FDA records list 78 510(k) clearances for Voco GmbH, from to . As of , FDA records show no recalls naming K061823.

Clearance record

Decision date
Received
(23 days to decision)
Product code
EBC Sealant, Pit And Fissure, And Conditioner
Regulation
21 CFR 872.3765
Device class
Class II
Review panel
Dental
Applicant
Voco GmbH Anton-Flettner-Strasse 1-3, Cuxhaven, DE
510(k) summary
Statement
Third party review
No

Clearances, product code EBC

Trailing 12 months
1 clearance under product code EBC in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260