Cleared Traditional

K203760 - Tokuyama Universal Bond II

K203760 is an FDA 510(k) clearance for Tokuyama Universal Bond II, 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 153-day FDA review.

K203760 · Tokuyama Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
153d
Days
Class 2
Risk

K203760 is an FDA 510(k) clearance for the Tokuyama Universal Bond II. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Tokuyama Dental Corporation (Tokyo, JP). The FDA issued a Cleared decision on May 25, 2021 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Tokuyama Dental Corporation devices

FDA 510(k) Submission Details - K203760

510(k) Number K203760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2020
Decision Date May 25, 2021
Days to Decision 153 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
26d slower than avg
Panel avg: 127d · This submission: 153d
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 Consultant

Fish & Richardson, P.C.
Keith A. Barritt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K203760.
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Ultra SEP
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R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
K192913 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Jan 2021
Bright Bond Universal
K200153 · Genoss Co., Ltd. · Oct 2020
BZF-29
K200682 · GC America, Inc. · Oct 2020