Cleared Traditional

K990736 - GC RELINE SOFT/EXTRA SOFT

K990736 is an FDA 510(k) clearance for GC RELINE SOFT/EXTRA SOFT, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K990736 · GC America, Inc. · Dental device
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May 1999
Decision
84d
Days
Class 2
Risk

K990736 is an FDA 510(k) clearance for the GC RELINE SOFT/EXTRA SOFT. 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 May 28, 1999 after a review of 84 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

FDA 510(k) Submission Details - K990736

510(k) Number K990736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1999
Decision Date May 28, 1999
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

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 239
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K990736.
HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
K992609 · Kay See Dental Mfg. Co. · Sep 1999
IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
K991996 · Denplus, Inc. · Sep 1999
ACRON MC MODIFICATION
K991774 · GC America, Inc. · Jul 1999
VITRON M
K990763 · Espe Dental AG · May 1999
VITRON H
K991220 · Espe Dental AG · May 1999
ORTHO-GLOW GLITTER
K990699 · Harry J. Bosworth Co. · May 1999