Cleared Traditional

K981691 - SILICONE SOFT RELINE

K981691 is an FDA 510(k) clearance for SILICONE SOFT RELINE, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K981691

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
Combination Product No
PCCP Authorized No
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.

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 217
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K981691.
PROTECH PLUS
K983547 · Protech, Inc. · Jan 1999
MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC
K983876 · Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind · Dec 1998
MUCOPREN SOFT RELINING SYSTEM
K983357 · Roydent Dental Products, Inc. · Nov 1998
GC RELINE
K982695 · GC America, Inc. · Oct 1998
LINER 1:HARD RELINE LIQUID
K981861 · Harry J. Bosworth Co. · Oct 1998
TOKUYAMA SOFRELINER
K982537 · Tokuyama America, Inc. · Aug 1998