Cleared Traditional

K973288 - STABILOR HN

K973288 is an FDA 510(k) clearance for STABILOR HN, manufactured by Degussa Corp.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K973288 · Degussa Corp. · Dental device
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Nov 1997
Decision
78d
Days
Class 2
Risk

K973288 is an FDA 510(k) clearance for the STABILOR HN. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Degussa Corp. (South Plainfield, US). The FDA issued a Cleared decision on November 19, 1997 after a review of 78 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 Degussa Corp. devices

FDA 510(k) Submission Details - K973288

510(k) Number K973288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1997
Decision Date November 19, 1997
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 156
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K973288.
D-SIGN I (R&D PROJECT DW263 #24)
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ALFALLOY
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K972683 · Metalor Dental USA Corp. · Aug 1997