Cleared Traditional

K921174 - COMPOSITE RESIN CORE PASTE MATERIAL

K921174 is the FDA 510(k) clearance for COMPOSITE RESIN CORE PASTE MATERIAL by Centrix, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K921174 · Centrix, Inc. · Dental device
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Sep 1992
Decision
174d
Days
Class 2
Risk

K921174 is an FDA 510(k) clearance for the COMPOSITE RESIN CORE PASTE MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Centrix, Inc. (Milford, US). The FDA issued a Cleared decision on September 1, 1992 after a review of 174 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Centrix, Inc. devices

Submission Details

510(k) Number K921174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1992
Decision Date September 01, 1992
Days to Decision 174 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
47d slower than avg
Panel avg: 127d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K921174.
ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT
K921602 · Ultradent Products, Inc. · Sep 1992
LITE FIL II A
K920892 · Shofu Dental Corp. · Sep 1992
LITE FILL II P
K920893 · Shofu Dental Corp. · Sep 1992
PULPDENT HARD CORE
K922755 · Pulpdent Corp. · Aug 1992
TETRIC LIGHT-CURING COMPOSITE
K922569 · Ivoclar North America, Inc. · Jul 1992
BISCO CORE PASTE
K921439 · Bisco, Inc. · May 1992