Cleared Traditional

K912708 - CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM

K912708 is an FDA 510(k) clearance for CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM, 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 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

FDA 510(k) Submission Details - K912708

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
Combination Product No
PCCP Authorized No
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.

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 K912708.
PALFIQUE LITEPOSTERIOR
K913099 · Tokuyama America, Inc. · Oct 1991
PALFIQUE INLAY
K913100 · Tokuyama America, Inc. · Oct 1991
CURAY SUPPORT
K912788 · Scientific Pharmaceuticals, Inc. · Aug 1991
DEGULUX LIGHT CURING UNIT
K912037 · Degussa AG · Jun 1991
CHARISMA
K910263 · Kulzer, Inc. · Jun 1991
PALFIQUE ESTELITE
K911524 · Tokuyama America, Inc. · May 1991