Cleared Traditional

K994056 - ADMIRA

K994056 is the FDA 510(k) clearance for ADMIRA by Voco GmbH. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K994056 · Voco GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
43d
Days
Class 2
Risk

K994056 is an FDA 510(k) clearance for the ADMIRA. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Voco GmbH (St Louis, US). The FDA issued a Cleared decision on January 12, 2000 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K994056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1999
Decision Date January 12, 2000
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K994056.
BUILD-IT FR
K000211 · Jeneric/Pentron, Inc. · Mar 2000
ARABESK FLOW
K994304 · Voco GmbH · Feb 2000
ARABESK TOP
K994268 · Voco GmbH · Feb 2000
FUJI II LC CAPSULE
K993973 · GC America, Inc. · Jan 2000
SOLITAIRE 2
K993932 · Heraeus Kulzer, Inc. · Dec 1999
PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
K993716 · Harry J. Bosworth Co. · Dec 1999