Cleared Traditional

K070215 - TOKUYAMA BOND FORCE

K070215 is an FDA 510(k) clearance for TOKUYAMA BOND FORCE, manufactured by Tokuyama Dental Corporation. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K070215 · Tokuyama Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
66d
Days
Class 2
Risk

K070215 is an FDA 510(k) clearance for the TOKUYAMA BOND FORCE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Tokuyama Dental Corporation (Washington, US). The FDA issued a Cleared decision on March 30, 2007 after a review of 66 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 Dental Corporation devices

FDA 510(k) Submission Details - K070215

510(k) Number K070215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2007
Decision Date March 30, 2007
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
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 318
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K070215.
FUTURABOND DC/SINGLE DOSE
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K063780 · Bisco, Inc. · Jan 2007