Cleared Traditional

K791005 - CHEMODENT CERAMIC METAL

K791005 is an FDA 510(k) clearance for CHEMODENT CERAMIC METAL, manufactured by Chemodent Dental Laboratory. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K791005 · Chemodent Dental Laboratory · Dental device
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Aug 1979
Decision
72d
Days
Class 2
Risk

K791005 is an FDA 510(k) clearance for the CHEMODENT CERAMIC METAL. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Chemodent Dental Laboratory (Mchenry, US). The FDA issued a Cleared decision on August 10, 1979 after a review of 72 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 Chemodent Dental Laboratory devices

FDA 510(k) Submission Details - K791005

510(k) Number K791005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1979
Decision Date August 10, 1979
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 128d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

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 172
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K791005.
TEMPO
K792274 · Deringer-Ney, Inc. · Nov 1979
HOWMEDICA A-35 DENTAL ALLOY
K791973 · Howmedica Corp. · Nov 1979
HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY
K792008 · Howmedica Corp. · Nov 1979
GDC-685
K790641 · Deringer-Ney, Inc. · May 1979
SALIVAN PARAEIGHT TOUGHNESS
K790096 · Den-Mat Corp. · Feb 1979
SALIVAN & SALIVAN BROWN
K790097 · Den-Mat Corp. · Feb 1979