Cleared Traditional

K925383 - PHOTO CLEARFIL OPAQUER

K925383 is an FDA 510(k) clearance for PHOTO CLEARFIL OPAQUER, manufactured by Kuraray Co.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K925383 · Kuraray Co. · Dental device
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Jan 1993
Decision
97d
Days
Class 2
Risk

K925383 is an FDA 510(k) clearance for the PHOTO CLEARFIL OPAQUER. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray Co. (New York, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 97 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 Co. devices

FDA 510(k) Submission Details - K925383

510(k) Number K925383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1992
Decision Date January 28, 1993
Days to Decision 97 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
30d faster than avg
Panel avg: 127d · This submission: 97d
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 799
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K925383.
VIVALUX
K926556 · Ivoclar North America, Inc. · Apr 1993
CLIP
K926418 · Voco GmbH · Mar 1993
PULPDENT DENTAL BOND ENCHANCER
K926074 · Pulpdent Corp. · Mar 1993
BISCO D/C RESINOMER
K924151 · Bisco, Inc. · Dec 1992
TRIAD INLAY COMPOSITE
K923236 · Dentsply Intl. · Sep 1992
COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE
K921407 · Ultradent Products, Inc. · Sep 1992