Cleared Traditional

K001913 - CLEARFIL ST OPAQUER

K001913 is an FDA 510(k) clearance for CLEARFIL ST OPAQUER, manufactured by Kuraray Company, Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K001913 · Kuraray Company, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
42d
Days
Class 2
Risk

K001913 is an FDA 510(k) clearance for the CLEARFIL ST OPAQUER. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray Company, Ltd. (New York, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 42 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 Kuraray Company, Ltd. devices

FDA 510(k) Submission Details - K001913

510(k) Number K001913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2000
Decision Date August 04, 2000
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
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 723
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K001913.
RENEW LS-1
K003317 · Bisco, Inc. · Nov 2000
IMPROVED TRY-IN GEL
K001899 · Sybron Dental Specialties, Inc. · Aug 2000
PRIMAFLOW
K002086 · Dmg USA, Inc. · Aug 2000
SCULPTURE FLOW
K001623 · Jeneric/Pentron, Inc. · Jul 2000
GRADIA
K001518 · GC America, Inc. · Jul 2000
SIGNUM
K001360 · J.F. Jelenko & Co., Inc. · Jun 2000