Cleared Traditional

K801277 - GDC 934

K801277 is the FDA 510(k) clearance for GDC 934 by Deringer-Ney, Inc.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K801277 · Deringer-Ney, Inc. · Dental device
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Jul 1980
Decision
53d
Days
Class 2
Risk

K801277 is an FDA 510(k) clearance for the GDC 934. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Deringer-Ney, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Deringer-Ney, Inc. devices

Submission Details

510(k) Number K801277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1980
Decision Date July 21, 1980
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJS Alloy, Other Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJS Alloy, Other Noble Metal

All 117
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K801277.
CLASS OF CASTING ALLOYS TYPE IV OR ALT
K820408 · Howmedica Corp. · Mar 1982
BAK-ON SP PORCELAIN ALLOY
K812101 · Johnson & Johnson Professionals, Inc. · Aug 1981
HOWMEDICA T-III G ALLOY
K810380 · Howmedica Corp. · Mar 1981
AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)
K800994 · Howmedica Corp. · May 1980
TEMPO
K792274 · Deringer-Ney, Inc. · Nov 1979
HOWMEDICA A-35 DENTAL ALLOY
K791973 · Howmedica Corp. · Nov 1979