Cleared Traditional

K896981 - TOKUSO REBASE

K896981 is an FDA 510(k) clearance for TOKUSO REBASE, manufactured by Tokuyama America, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K896981 · Tokuyama America, Inc. · Dental device
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May 1990
Decision
153d
Days
Class 2
Risk

K896981 is an FDA 510(k) clearance for the TOKUSO REBASE. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Tokuyama America, Inc. (Washington, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 153 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 America, Inc. devices

FDA 510(k) Submission Details - K896981

510(k) Number K896981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date May 15, 1990
Days to Decision 153 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
26d slower than avg
Panel avg: 127d · This submission: 153d
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 Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 163
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K896981.
PALAPRESS(R) VARIO RESIN
K902115 · Kulzer, Inc. · Jul 1990
PALADON(R) 65
K901789 · Kulzer, Inc. · Jun 1990
PALFIQUE LIGHT LINER
K896980 · Tokuyama America, Inc. · May 1990
SR-IVOCAP
K896130 · Ivoclar North America, Inc. · Apr 1990
SR-IVOSEAL
K896139 · Ivoclar North America, Inc. · Apr 1990
ORTHO-KEV APPLIANCE REINFORCING SYSTEM
K895714 · American Orthodontics · Dec 1989