Cleared Traditional

K190940 - Tokuyama Rebase III

K190940 is an FDA 510(k) clearance for Tokuyama Rebase III, manufactured by Tokuyama Dental Corporation. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K190940 · Tokuyama Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
177d
Days
Class 2
Risk

K190940 is an FDA 510(k) clearance for the Tokuyama Rebase III. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Tokuyama Dental Corporation (Tokyo, JP). The FDA issued a Cleared decision on October 4, 2019 after a review of 177 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 - K190940

510(k) Number K190940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2019
Decision Date October 04, 2019
Days to Decision 177 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 slower than avg
Panel avg: 127d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 157
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K190940.
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