Cleared Traditional

K911525 - TOKUSO LIGHT BOND

K911525 is an FDA 510(k) clearance for TOKUSO LIGHT BOND, manufactured by Tokuyama America, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K911525 · Tokuyama America, Inc. · Dental device
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May 1991
Decision
40d
Days
Class 2
Risk

K911525 is an FDA 510(k) clearance for the TOKUSO LIGHT BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Tokuyama America, Inc. (Washington, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 40 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 Tokuyama America, Inc. devices

FDA 510(k) Submission Details - K911525

510(k) Number K911525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1991
Decision Date May 15, 1991
Days to Decision 40 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 127d · This submission: 40d
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 331
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K911525.
PULPDENT ENAMEL BONDING AGENT
K911282 · Pulpdent Corp. · Sep 1991
CLEARFIL LINER BOND SYSTEM
K912707 · Kuraray Co. · Aug 1991
PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
K912256 · Lee Pharmaceuticals · Jul 1991
ALL-BOND 2
K910860 · Bisco, Inc. · Apr 1991
ALL BOND LINER-F
K910628 · Bisco, Inc. · Mar 1991
DENTHESIVE
K905302 · Kulzer, Inc. · Feb 1991