Cleared Traditional

K033970 - CLEARFIL PHOTO CORE PLT

K033970 is the FDA 510(k) clearance for CLEARFIL PHOTO CORE PLT by Kuraray Medical, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K033970 · Kuraray Medical, Inc. · Dental device
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Mar 2004
Decision
95d
Days
Class 2
Risk

K033970 is an FDA 510(k) clearance for the CLEARFIL PHOTO CORE PLT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on March 26, 2004 after a review of 95 days - within the typical 510(k) review window.

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 Kuraray Medical, Inc. devices

Submission Details

510(k) Number K033970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2003
Decision Date March 26, 2004
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
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 515
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K033970.
GRADIA DIRECT LOFLO
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MULTICORE HB
K040795 · Ivoclar Vivadent, Inc. · May 2004
GRADIA GUM
K033808 · GC America, Inc. · Feb 2004
VENUS FLOW
K033665 · Heraeus Kulzer, Inc. · Dec 2003
EPRICORD
K033267 · Kuraray Medical, Inc. · Dec 2003