Cleared Traditional

K831097 - CONCERTO

K831097 is an FDA 510(k) clearance for CONCERTO, manufactured by Unitek Corp.. 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.

K831097 · Unitek Corp. · Dental device
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Jun 1983
Decision
72d
Days
Class 2
Risk

K831097 is an FDA 510(k) clearance for the CONCERTO. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Unitek Corp. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1983 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 Unitek Corp. devices

FDA 510(k) Submission Details - K831097

510(k) Number K831097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date June 15, 1983
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · 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 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K831097.
DEVA 4
K832530 · Degussa Dental, Inc. · Sep 1983
X-704
K832253 · Unitek Corp. · Aug 1983
STROMA II
K831096 · Unitek Corp. · Jun 1983
RX UNIVERSAL
K822950 · Jeneric Ind. · Oct 1982
NEW CROWN AND BRIDGE ALLOY NO. DW196
K822419 · Williams Gold Refining Co., Inc. · Aug 1982
82 ALLOY
K821798 · J. Aderer, Inc. · Jul 1982