Cleared Traditional

K080724 - GC OPB-100

K080724 is an FDA 510(k) clearance for GC OPB-100, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K080724 · GC America, Inc. · Dental device
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Jun 2008
Decision
89d
Days
Class 2
Risk

K080724 is an FDA 510(k) clearance for the GC OPB-100. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on June 11, 2008 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 - K080724

510(k) Number K080724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2008
Decision Date June 11, 2008
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 141
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K080724.
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THERMA-CURE
K071590 · Reliance Orthodontic Products, Inc. · Jul 2007
GRENGLOO
K061481 · Ormco Corp. · Jul 2006