Cleared Traditional

K982537 - TOKUYAMA SOFRELINER

K982537 is an FDA 510(k) clearance for TOKUYAMA SOFRELINER, 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 34-day FDA review.

K982537 · Tokuyama America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
34d
Days
Class 2
Risk

K982537 is an FDA 510(k) clearance for the TOKUYAMA SOFRELINER. 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 August 24, 1998 after a review of 34 days - a notably fast clearance 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: 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 - K982537

510(k) Number K982537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1998
Decision Date August 24, 1998
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
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 K982537.
SILICONE SOFT RELINE
K981691 · Harry J. Bosworth Co. · Nov 1998
GC RELINE
K982695 · GC America, Inc. · Oct 1998
LINER 1:HARD RELINE LIQUID
K981861 · Harry J. Bosworth Co. · Oct 1998
KERR HARD DENTURE RELINE MATERIAL
K981448 · Sybron Dental Specialties, Inc. · Jun 1998
CSR
K974865 · Parkell, Inc. · Mar 1998
UFI GEL C
K974772 · Voco GmbH · Feb 1998