Cleared Traditional

K912707 - CLEARFIL LINER BOND SYSTEM

K912707 is an FDA 510(k) clearance for CLEARFIL LINER BOND SYSTEM, manufactured by Kuraray Co.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K912707 · Kuraray Co. · Dental device
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Aug 1991
Decision
62d
Days
Class 2
Risk

K912707 is an FDA 510(k) clearance for the CLEARFIL LINER BOND SYSTEM. Classified as Agent, Tooth Bonding, Resin (product code KLE), 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 872.3200 - 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 - K912707

510(k) Number K912707 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.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 380
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K912707.
ESPE(R) -SIL
K913965 · Espe GmbH (Us) · Dec 1991
IMPERVA DUAL
K913946 · Shofu Dental Corp. · Dec 1991
PULPDENT ENAMEL BONDING AGENT
K911282 · Pulpdent Corp. · Sep 1991
PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
K912256 · Lee Pharmaceuticals · Jul 1991
TOKUSO LIGHT BOND
K911525 · Tokuyama America, Inc. · May 1991
ALL-BOND 2
K910860 · Bisco, Inc. · Apr 1991