Cleared Traditional

K953589 - TOKUYAMA SOFT RELINING

K953589 is an FDA 510(k) clearance for TOKUYAMA SOFT RELINING, 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 170-day FDA review.

K953589 · Tokuyama America, Inc. · Dental device
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Jan 1996
Decision
170d
Days
Class 2
Risk

K953589 is an FDA 510(k) clearance for the TOKUYAMA SOFT RELINING. 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 January 18, 1996 after a review of 170 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 - K953589

510(k) Number K953589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date January 18, 1996
Days to Decision 170 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 127d · This submission: 170d
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 K953589.
V.R.S. DENTURE RESIN MATERIAL
K962333 · Vident · Aug 1996
QUICKSPLINT
K961995 · Heraeus Kulzer, Inc. · Jun 1996
BOSWORTH LIQUID RESIN II
K961200 · Harry J. Bosworth Co. · May 1996
AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER
K954637 · American Dental Products, Inc. · Dec 1995
CONNECT
K954689 · Sybron Dental Specialties, Inc. · Oct 1995
PALASPLINT
K953743 · Heraeus Kulzer, Inc. · Oct 1995