Cleared Traditional

K911671 - CERADELTA

K911671 is the FDA 510(k) clearance for CERADELTA by Metalor Dental USA Corp.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K911671 · Metalor Dental USA Corp. · Dental device
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Jul 1991
Decision
90d
Days
Class 2
Risk

K911671 is an FDA 510(k) clearance for the CERADELTA. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on July 10, 1991 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Metalor Dental USA Corp. devices

Submission Details

510(k) Number K911671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date July 10, 1991
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 117
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K911671.
STANDARD S3
K912305 · Metalor Dental USA Corp. · Aug 1991
STANDARD S31
K912307 · Metalor Dental USA Corp. · Aug 1991
STANDARD S32
K912308 · Metalor Dental USA Corp. · Aug 1991
V-DELTA
K911545 · Metalor Dental USA Corp. · Jul 1991
800 SOLDER
K912314 · Metalor Dental USA Corp. · Jul 1991
V-DELTA S1
K912315 · Metalor Dental USA Corp. · Jul 1991