Cleared Traditional

K792210 - GDC 802-DEVELOPMENT NAME

K792210 is the FDA 510(k) clearance for GDC 802-DEVELOPMENT NAME by Deringer-Ney, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K792210 · Deringer-Ney, Inc. · Dental device
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Nov 1979
Decision
18d
Days
Class 2
Risk

K792210 is an FDA 510(k) clearance for the GDC 802-DEVELOPMENT NAME. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Deringer-Ney, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1979 after a review of 18 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 K792210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1979
Decision Date November 20, 1979
Days to Decision 18 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
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJT Alloy, Gold-based 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 - EJT Alloy, Gold-based Noble Metal

All 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K792210.
NEY-ORO 60
K831280 · Deringer-Ney, Inc. · Jun 1983
GDC-1130
K820277 · Deringer-Ney, Inc. · Feb 1982
GDC-1054
K810789 · Deringer-Ney, Inc. · Apr 1981
HOWMEDICA A-30 DENTAL ALLOY
K791304 · Howmedica Corp. · Oct 1979
DEVELOPMENT NO. 647
K790414 · Deringer-Ney, Inc. · Apr 1979
GDC-591
K790006 · Deringer-Ney, Inc. · Feb 1979