Cleared Traditional

K974772 - UFI GEL C

K974772 is the FDA 510(k) clearance for UFI GEL C by Voco GmbH. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K974772 · Voco GmbH · Dental device
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Feb 1998
Decision
50d
Days
Class 2
Risk

K974772 is an FDA 510(k) clearance for the UFI GEL C. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Voco GmbH (St Louis, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 K974772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1997
Decision Date February 10, 1998
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 127d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 140
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K974772.
LINER 1:HARD RELINE LIQUID
K981861 · Harry J. Bosworth Co. · Oct 1998
KERR HARD DENTURE RELINE MATERIAL
K981448 · Sybron Dental Specialties, Inc. · Jun 1998
CSR
K974865 · Parkell, Inc. · Mar 1998
LIQCRYLIC PRO DENTAL RESIN
K972573 · Dentsply Intl. · Sep 1997
TRUBYTE SOFT RELINE SYSTEM
K964040 · Dentsply Intl. · Dec 1996
SOFT DENTURE REBASING RESIN
K963736 · Sybron Dental Specialties, Inc. · Dec 1996