Cleared Special

K061823 - ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE

K061823 is an FDA 510(k) clearance for ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EBC cleared through the Special 510(k) pathway after a 23-day FDA review.

K061823 · Voco GmbH · Dental device
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Jul 2006
Decision
23d
Days
Class 2
Risk

K061823 is an FDA 510(k) clearance for the ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on July 21, 2006 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Voco GmbH devices

FDA 510(k) Submission Details - K061823

510(k) Number K061823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2006
Decision Date July 21, 2006
Days to Decision 23 days
Submission Type Special
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
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

EBC Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K061823.
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
K062886 · CAO Group, Inc. · Nov 2006
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997 · Premier Dental Products Co. · Oct 2006
GRANDIO SEAL
K062344 · Voco GmbH · Oct 2006
EMBRACE WETBOND CLEAR SEALANT
K052281 · Pulpdent Corporation · Feb 2006
ASCENT PIT & FISSURE SEALANT
K053089 · CAO Group, Inc. · Dec 2005
BOSWORTH SEAL
K051224 · Harry J. Bosworth Co. · Jul 2005