Cleared Traditional

K981691 - SILICONE SOFT RELINE

K981691 is the FDA 510(k) clearance for SILICONE SOFT RELINE by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K981691 · Harry J. Bosworth Co. · Dental device
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Nov 1998
Decision
174d
Days
Class 2
Risk

K981691 is an FDA 510(k) clearance for the SILICONE SOFT RELINE. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on November 3, 1998 after a review of 174 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K981691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1998
Decision Date November 03, 1998
Days to Decision 174 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 127d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 129
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K981691.
GC RELINE SOFT/EXTRA SOFT
K990736 · GC America, Inc. · May 1999
JELDENT MULTICRYL
K990056 · J.F. Jelenko & Co., Inc. · Mar 1999
GC UNIFAST TRAD
K984365 · GC America, Inc. · Feb 1999
GC RELINE
K982695 · GC America, Inc. · Oct 1998
KERR HARD DENTURE RELINE MATERIAL
K981448 · Sybron Dental Specialties, Inc. · Jun 1998
CSR
K974865 · Parkell, Inc. · Mar 1998