Cleared Traditional

K954976 - POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)

K954976 is an FDA 510(k) clearance for POTASSIUM NITRATE ZINC OXIDE EUGENOL TE..., manufactured by Healex Products, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K954976 · Healex Products, Inc. · Dental device
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Apr 1996
Decision
181d
Days
Class 2
Risk

K954976 is an FDA 510(k) clearance for the POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION). Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Healex Products, Inc. (Providence, US). The FDA issued a Cleared decision on April 25, 1996 after a review of 181 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Healex Products, Inc. devices

FDA 510(k) Submission Details - K954976

510(k) Number K954976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1995
Decision Date April 25, 1996
Days to Decision 181 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
54d slower than avg
Panel avg: 127d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 130
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K954976.
TEMPFIL F
K963786 · Sybron Dental Specialties, Inc. · Nov 1996
BOSWORTH TEMPORARY RESIN
K961199 · Harry J. Bosworth Co. · Jun 1996
BOSWORTH CH I
K961198 · Harry J. Bosworth Co. · May 1996
PROV-KB
K960938 · Silicon-Und Composite Spezialitaten GmbH · Apr 1996
ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL
K960122 · Wallace A. Erickson & Co. · Feb 1996
BELLEGLASHP
K955331 · Sybron Dental Specialties, Inc. · Jan 1996