Cleared Traditional

K993917 - TOKUYAMA ONE-UP-BOND F

K993917 is an FDA 510(k) clearance for TOKUYAMA ONE-UP-BOND F, 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 77-day FDA review.

K993917 · Tokuyama America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
77d
Days
Class 2
Risk

K993917 is an FDA 510(k) clearance for the TOKUYAMA ONE-UP-BOND F. 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 February 2, 2000 after a review of 77 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 - K993917

510(k) Number K993917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1999
Decision Date February 02, 2000
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 127d · This submission: 77d
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 K993917.
KERR GEL ETCHANT
K000954 · Sybron Dental Specialties, Inc. · Apr 2000
BOND 1 C & B
K994359 · Jeneric/Pentron, Inc. · Mar 2000
RESIN TOOTH BONDING AGENT
K994302 · Parkell, Inc. · Feb 2000
PULPDENT UNO-DUO
K993683 · Pulpdent Corp. · Dec 1999
GLUMA COMFORT BOND
K992985 · Heraeus Kulzer, Inc. · Oct 1999
GLUMA COMFORT BOND + DESENSITIZER
K992292 · Heraeus Kulzer, Inc. · Oct 1999