Cleared Traditional

K911042 - GAMMAT ELECTROFORMED GOLD COPING

K911042 is an FDA 510(k) clearance for GAMMAT ELECTROFORMED GOLD COPING, manufactured by Gramm Surface Technology, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K911042 · Gramm Surface Technology, Inc. · Dental device
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May 1991
Decision
82d
Days
Class 2
Risk

K911042 is an FDA 510(k) clearance for the GAMMAT ELECTROFORMED GOLD COPING. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Gramm Surface Technology, Inc. (Dumfries, US). The FDA issued a Cleared decision on May 29, 1991 after a review of 82 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 Gramm Surface Technology, Inc. devices

FDA 510(k) Submission Details - K911042

510(k) Number K911042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date May 29, 1991
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

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 552
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K911042.
SOLCHROM-PAL
K912313 · Metalor Dental USA Corp. · Aug 1991
VS1G
K912297 · Metalor Dental USA Corp. · Jun 1991
INLAY 90
K911546 · Metalor Dental USA Corp. · Jun 1991
V-GNATHOS
K911530 · Metalor Dental USA Corp. · Apr 1991
V-SUPERGOLD
K911531 · Metalor Dental USA Corp. · Apr 1991
V-SUPER
K911532 · Metalor Dental USA Corp. · Apr 1991