Cleared Traditional

K912708 - CLEARFIL PHOTO ANTERIOR & LINER BOND SY...

K912708 is the FDA 510(k) clearance for CLEARFIL PHOTO ANTERIOR & LINER BOND SY... by Kuraray Co.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K912708 · Kuraray Co. · Dental device
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Aug 1991
Decision
62d
Days
Class 2
Risk

K912708 is an FDA 510(k) clearance for the CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM. 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 August 20, 1991 after a review of 62 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 Co. devices

Submission Details

510(k) Number K912708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1991
Decision Date August 20, 1991
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
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 579
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K912708.
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DEGULUX LIGHT CURING UNIT
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CHARISMA
K910263 · Kulzer, Inc. · Jun 1991
VISIO-GEM ART-SYSTEM
K905604 · Espe GmbH (Us) · Mar 1991