Cleared Traditional

K980800 - LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL

K980800 is an FDA 510(k) clearance for LOW VISCOSITY COMPOSITE TEMPORARY (PROV..., manufactured by Cosmedent, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K980800 · Cosmedent, Inc. · Dental device
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Nov 1998
Decision
252d
Days
Class 2
Risk

K980800 is an FDA 510(k) clearance for the LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on November 9, 1998 after a review of 252 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 Cosmedent, Inc. devices

FDA 510(k) Submission Details - K980800

510(k) Number K980800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1998
Decision Date November 09, 1998
Days to Decision 252 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
125d slower than avg
Panel avg: 127d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 807
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K980800.
QUADRANT UNICHEM
K983751 · Cavex Holland BV · Nov 1998
QUADRANT ANTERIOR SHINE
K983549 · Cavex Holland BV · Nov 1998
PRODIGY- 3
K983370 · Sybron Dental Specialties, Inc. · Nov 1998
ELAN-2
K983091 · Kerr Dental Materials Center · Oct 1998
STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC
K982692 · Sterngold/Implamed · Oct 1998
CHROMA ZONE COLOR STAIN
K982259 · Kuraray America, Inc. · Sep 1998