Cleared Traditional

GDC-1136 CASTING ALLOY FOR PORCELAIN-FU (K813200) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K813200 · Ney · Dental device
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Dec 1981
Decision
48d
Days
Class 2
Risk

K813200 is an FDA 510(k) clearance for the GDC-1136 CASTING ALLOY FOR PORCELAIN-FU. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Ney (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 48 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 Ney devices

Submission Details

510(k) Number K813200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1981
Decision Date December 31, 1981
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
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 24
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K813200.
CLASS OF CASTING ALLOYS TYPE III OR ALT
K820434 · Howmedica Corp. · Mar 1982
CLASS OF PRECIOUS METAL CASTING ALLOYS
K820407 · Howmedica Corp. · Mar 1982
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