Cleared Traditional

K820277 - GDC-1130

K820277 is the FDA 510(k) clearance for GDC-1130 by Deringer-Ney, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K820277 · Deringer-Ney, Inc. · Dental device
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Feb 1982
Decision
22d
Days
Class 2
Risk

K820277 is an FDA 510(k) clearance for the GDC-1130. 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 February 24, 1982 after a review of 22 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 K820277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1982
Decision Date February 24, 1982
Days to Decision 22 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
105d faster than avg
Panel avg: 127d · This submission: 22d
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 K820277.
NEY-ORO 41
K870677 · Deringer-Ney, Inc. · May 1987
GDC 1824
K865049 · Deringer-Ney, Inc. · Mar 1987
NEY-ORO 60
K831280 · Deringer-Ney, Inc. · Jun 1983
GDC-1054
K810789 · Deringer-Ney, Inc. · Apr 1981
GDC 802-DEVELOPMENT NAME
K792210 · Deringer-Ney, Inc. · Nov 1979
HOWMEDICA A-30 DENTAL ALLOY
K791304 · Howmedica Corp. · Oct 1979