Cleared Traditional

K880764 - G-CERA PORCELAIN & G-CERA PORCELAIN MOD...

K880764 is an FDA 510(k) clearance for G-CERA PORCELAIN & G-CERA PORCELAIN MOD..., manufactured by G-C Intl. Corp.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K880764 · G-C Intl. Corp. · Dental device
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Apr 1988
Decision
46d
Days
Class 2
Risk

K880764 is an FDA 510(k) clearance for the G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by G-C Intl. Corp. (Scottsdale, US). The FDA issued a Cleared decision on April 12, 1988 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 - K880764

510(k) Number K880764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date April 12, 1988
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELL Device Classification - Class 2, Special Controls

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 - ELL Teeth, Porcelain

All 29
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K880764.
CRYSTAR(TM) ANTI-GREENING LIQUID
K893481 · Shofu Dental Corp. · Jul 1989
CRYSTAR(TM) VINTAGE PORCELAIN
K884214 · Shofu Dental Corp. · Dec 1988
SPECTRUM
K880774 · Dentsply Intl. · May 1988
DEN-MAT PORETCH (PORCELAIN ETCHANT)
K875351 · Den-Mat Corp. · Mar 1988
DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM
K871808 · Degussa Dental, Inc. · Jun 1987
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · Dentsply Intl. · Feb 1987