Cleared Traditional

K880765 - G-CERA PORCELAIN BOND

K880765 is an FDA 510(k) clearance for G-CERA PORCELAIN BOND, manufactured by G-C Intl. Corp.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K880765 · G-C Intl. Corp. · Dental device
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Apr 1988
Decision
52d
Days
Class 2
Risk

K880765 is an FDA 510(k) clearance for the G-CERA PORCELAIN BOND. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by G-C Intl. Corp. (Scottsdale, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 52 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 G-C Intl. Corp. devices

FDA 510(k) Submission Details - K880765

510(k) Number K880765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date April 18, 1988
Days to Decision 52 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 127d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 665
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K880765.
FORTIFY
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BISCOLOR
K875256 · Bisco, Inc. · Feb 1988