Cleared Traditional

K911546 - INLAY 90

K911546 is the FDA 510(k) clearance for INLAY 90 by Metalor Dental USA Corp.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K911546 · Metalor Dental USA Corp. · Dental device
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Jun 1991
Decision
66d
Days
Class 2
Risk

K911546 is an FDA 510(k) clearance for the INLAY 90. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 66 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 Metalor Dental USA Corp. devices

Submission Details

510(k) Number K911546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date June 06, 1991
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
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 K911546.
AUROFILM MP
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SOLCHROM-PAL
K912313 · Metalor Dental USA Corp. · Aug 1991
VS1G
K912297 · 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