Cleared Traditional

K991774 - ACRON MC MODIFICATION

K991774 is the FDA 510(k) clearance for ACRON MC MODIFICATION by GC America, Inc.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K991774 · GC America, Inc. · Dental device
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Jul 1999
Decision
45d
Days
Class 2
Risk

K991774 is an FDA 510(k) clearance for the ACRON MC MODIFICATION. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on July 9, 1999 after a review of 45 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 GC America, Inc. devices

Submission Details

510(k) Number K991774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1999
Decision Date July 09, 1999
Days to Decision 45 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
82d faster than avg
Panel avg: 127d · This submission: 45d
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 K991774.
VERSYO.COM
K010800 · Heraeus Kulzer, Inc. · May 2001
UFI GEL HARD
K993827 · Voco GmbH · Jan 2000
LUCITONE FRS FLEXIBEL DENTAL RESIN
K992956 · Dentsply Intl. · Oct 1999
GC RELINE SOFT/EXTRA SOFT
K990736 · GC America, Inc. · May 1999
ORTHO-GLOW GLITTER
K990699 · Harry J. Bosworth Co. · May 1999
JELDENT MULTICRYL
K990056 · J.F. Jelenko & Co., Inc. · Mar 1999