Cleared Traditional

CLEARFIL LINER BOND 2 (K936100) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K936100 · Kuraray Intl. Corp. · Dental device
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Feb 1994
Decision
43d
Days
Class 2
Risk

K936100 is an FDA 510(k) clearance for the CLEARFIL LINER BOND 2. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kuraray Intl. Corp. (New York, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 43 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 Intl. Corp. devices

Submission Details

510(k) Number K936100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1993
Decision Date February 03, 1994
Days to Decision 43 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
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K936100.
PRIME & BOND DIRECT COMPOSITE BONDING AGENT
K951864 · Dentsply Intl. · May 1995
SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM
K942493 · 3M Company · Jul 1994
FLUORIDE-PSA PRIME/ADHESIVE
K941572 · Dentsply Intl. · Jun 1994
NEW DENTINE ADHESIVE
K931812 · Dentsply Intl. · Jul 1993
NEW DENTIN PRIMER
K930504 · Dentsply Intl. · May 1993
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K920424 · 3M Company · Mar 1992