Cleared Traditional

K932039 - G-CERA ORBIT COLOUR COMMUNICATION SET

K932039 is the FDA 510(k) clearance for G-CERA ORBIT COLOUR COMMUNICATION SET by GC America, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K932039 · GC America, Inc. · Dental device
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Jul 1993
Decision
72d
Days
Class 2
Risk

K932039 is an FDA 510(k) clearance for the G-CERA ORBIT COLOUR COMMUNICATION SET. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 K932039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1993
Decision Date July 08, 1993
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K932039.
SOFTWEAR PORCELAIN SYSTEM
K943582 · Dentsply Intl. · Aug 1994
VITA CELAY BLANKS AND VITA CELAY OPTIMIZER
K934195 · Vident · Mar 1994
FINESSE PORCELAIN SYSTEM
K940252 · Dentsply Intl. · Mar 1994
BISCO PORCELAIN ETCHING GEL
K926238 · Bisco, Inc. · Mar 1993
JELENKO PORCELAIN SYSTEM PVS PROCELAIN
K923717 · J.F. Jelenko & Co., Inc. · Mar 1993
DENTAL PORCELAIN
K921619 · Dentsply Intl. · Jul 1992