Cleared Traditional

K943168 - CLEARFIL AP-X

K943168 is an FDA 510(k) clearance for CLEARFIL AP-X, 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 40-day FDA review.

K943168 · Kuraray Company, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
40d
Days
Class 2
Risk

K943168 is an FDA 510(k) clearance for the CLEARFIL AP-X. 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 10, 1994 after a review of 40 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 - K943168

510(k) Number K943168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1994
Decision Date August 10, 1994
Days to Decision 40 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
87d faster than avg
Panel avg: 127d · This submission: 40d
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 724
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K943168.
PULPDENT CERVICAL RESTORATIVE
K945113 · Pulpdent Corp. · Dec 1994
PRODIGY
K944659 · Sybron Dental Specialties, Inc. · Dec 1994
HERCULITE XR & XRV
K943642 · Sybron Dental Specialties, Inc. · Nov 1994
ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN
K942767 · Wallace A. Erickson & Co. · Jul 1994
SDI COMPOSTIES
K941899 · Southern Dental Industries, Inc. · Jul 1994
CAULK TOOTH CONDITIONER GEL AND SYRINGE
K942031 · Dentsply Intl. · Jun 1994