Cleared Traditional

K831096 - STROMA II

K831096 is the FDA 510(k) clearance for STROMA II by Unitek Corp.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K831096 · Unitek Corp. · Dental device
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Jun 1983
Decision
72d
Days
Class 2
Risk

K831096 is an FDA 510(k) clearance for the STROMA II. 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

Submission Details

510(k) Number K831096 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
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.

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 120
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K831096.
GDC-1489 A CASTING ALLOY
K850103 · Deringer-Ney, Inc. · Feb 1985
CERAMCO * HIGH FUSING FOIL SOLDER
K833434 · Johnson & Johnson Professionals, Inc. · Dec 1983
GDC 1448 DEVELOPMENT NAME
K833596 · Deringer-Ney, Inc. · Dec 1983
T-IV ELITE ALLOY
K820530 · Howmedica Corp. · Mar 1982
CLASS OF CASTING ALLOYS TYPE I OR ALTER
K820432 · Howmedica Corp. · Mar 1982
CLASS OF CASTING ALLOYS TYPE II OR ALTER
K820433 · Howmedica Corp. · Mar 1982