Cleared Traditional

K974494 - RENAMEL FLOWABLE COMPOSITE

K974494 is the FDA 510(k) clearance for RENAMEL FLOWABLE COMPOSITE by Cosmedent, Inc.. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K974494 · Cosmedent, Inc. · Dental device
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Feb 1998
Decision
74d
Days
Class 2
Risk

K974494 is an FDA 510(k) clearance for the RENAMEL FLOWABLE COMPOSITE. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Cosmedent, Inc. devices

Submission Details

510(k) Number K974494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1997
Decision Date February 10, 1998
Days to Decision 74 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
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 38
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K974494.
GINDA GUARD
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K862590 · 3M Company · Jul 1986
ESPE KETAC-BOND
K844845 · Espe GmbH (Us) · Aug 1985