Cleared Traditional

K021842 - ADMIRA SEAL

K021842 is the FDA 510(k) clearance for ADMIRA SEAL by Voco GmbH. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K021842 · Voco GmbH · Dental device
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Jul 2002
Decision
54d
Days
Class 2
Risk

K021842 is an FDA 510(k) clearance for the ADMIRA SEAL. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Voco GmbH (Bend, US). The FDA issued a Cleared decision on July 29, 2002 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Voco GmbH devices

Submission Details

510(k) Number K021842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2002
Decision Date July 29, 2002
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 127d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBC Sealant, Pit And Fissure, And Conditioner

All 62
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K021842.
BOSWORTH SEAL
K051224 · Harry J. Bosworth Co. · Jul 2005
AEGIS PIT & FISSURE SEALANT WITH ACP
K033751 · Harry J. Bosworth Co. · Feb 2004
PIT & FISSURE SEALANT WITH FLUORIDE
K031811 · Harry J. Bosworth Co. · Sep 2003
ADMIRA PROTECT
K021844 · Voco GmbH · Jul 2002
REVOTEK LC
K012542 · GC America, Inc. · Oct 2001
TEETHMATE F-1
K012742 · Kuraray Medical, Inc. · Sep 2001