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.

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

105d faster than avg

Panel avg: 128d · 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 128

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

FDA 510(k) Resources - Dental

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K061823

Voco GmbH

Cuxhaven · DE

MICHAEL SUS

Regulatory profile

119 submissions 119 cleared

100% clearance rate · Active in Dental

View all devices by Voco GmbH →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: July 21, 2006. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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