Cleared Traditional

K974494 - RENAMEL FLOWABLE COMPOSITE

K974494 is an FDA 510(k) clearance for RENAMEL FLOWABLE COMPOSITE, manufactured by Cosmedent, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K974494

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.

EBD Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K974494.
BELLEGLAZE
K992067 · Kerr Dental Materials Center · Aug 1999
CORE-IDE
K984037 · Roydent Dental Products, Inc. · Feb 1999
FLOWABLE HYBRID
K980298 · Cosmedent, Inc. · Mar 1998
NO-STICK COMPOSITE INSTRUMENT DIP
K901050 · Pulpdent Corp. · Apr 1990
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590 · 3M Company · Jul 1986
AUSTENAL DENTAL COMPOSITE RESIN
K854957 · Austenal Dental, Inc. · Jan 1986