Cleared Traditional

LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL (K980800) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K980800.
3M ESPE HAUR
K010781 · 3M Company · Apr 2001
3M LVR SYSTEM
K991961 · 3M Company · Aug 1999
R-30 AESTHETIC RESTORATIVE
K984387 · Dentsply Intl. · Jan 1999
SPECTRUM 800 CURING UNIT
K982318 · Dentsply Intl. · Sep 1998
DYTRACT FLOW RESTORATIVE
K982395 · Dentsply Intl. · Aug 1998
3M DENT II SYSTEM
K981647 · 3M Company · Aug 1998