Cleared Traditional

K980661 - CERA E DENTAL ALLOY

K980661 is an FDA 510(k) clearance for CERA E DENTAL ALLOY, manufactured by European Dental Imports, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K980661 · European Dental Imports, Inc. · Dental device
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May 1998
Decision
70d
Days
Class 2
Risk

K980661 is an FDA 510(k) clearance for the CERA E DENTAL ALLOY. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by European Dental Imports, Inc. (Durham, US). The FDA issued a Cleared decision on May 1, 1998 after a review of 70 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 European Dental Imports, Inc. devices

FDA 510(k) Submission Details - K980661

510(k) Number K980661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1998
Decision Date May 01, 1998
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
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 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K980661.
SILCAST (CODE NAME RD-0118)
K981247 · J.F. Jelenko & Co., Inc. · Jul 1998
ORION VESTA DENTAL ALLOY
K981001 · European Dental Imports, Inc. · May 1998
ORION WX DENTAL ALLOY
K981002 · European Dental Imports, Inc. · May 1998
AURENORM 68
K972945 · Aurex Precious Metal Industries (Pty)Ltd · Nov 1997
STABILOR HN
K973288 · Degussa Corp. · Nov 1997
VERA SOLDER
K972533 · Aalba Dent, Inc. · Sep 1997