Cleared Traditional

K033970 - CLEARFIL PHOTO CORE PLT

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

K033970 · Kuraray Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K033970

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.

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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K033970.
COSMEDENT CORE PASTE
K040994 · Cosmedent, Inc. · Jun 2004
MULTICORE HB
K040795 · Ivoclar Vivadent, Inc. · May 2004
QUIXX POSTERIOR RESTORATIVE
K040144 · Dentsply International · Apr 2004
HERMES
K033996 · 3M Espe AG Dental Products · Feb 2004
GRADIA GUM
K033808 · GC America, Inc. · Feb 2004
CONCEPT HP ADD-ON
K033773 · Ivoclar Vivadent, AG · Jan 2004