Cleared Traditional

K003034 - COLTENE AURA COMPOMER RESTORATIVE SYSTEM

K003034 is an FDA 510(k) clearance for COLTENE AURA COMPOMER RESTORATIVE SYSTEM, manufactured by Coltene/Whaledent, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K003034 · Coltene/Whaledent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
63d
Days
Class 2
Risk

K003034 is an FDA 510(k) clearance for the COLTENE AURA COMPOMER RESTORATIVE SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on November 30, 2000 after a review of 63 days - a notably fast clearance 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: 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 Coltene/Whaledent, Inc. devices

FDA 510(k) Submission Details - K003034

510(k) Number K003034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2000
Decision Date November 30, 2000
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 670
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K003034.
TETRIC CERAM HB
K010250 · Ivoclar North America, Inc. · Feb 2001
PALFIQUE ESTELITE LV CLEAR
K010267 · Tokuyama America, Inc. · Feb 2001
PALFIQUE ESTELITE LV
K002863 · Tokuyama America, Inc. · Jan 2001
RENEW LS-2
K003361 · Bisco, Inc. · Nov 2000
RENEW LS-1
K003317 · Bisco, Inc. · Nov 2000
IMPROVED TRY-IN GEL
K001899 · Sybron Dental Specialties, Inc. · Aug 2000