Cleared Traditional

K961199 - BOSWORTH TEMPORARY RESIN

K961199 is the FDA 510(k) clearance for BOSWORTH TEMPORARY RESIN by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K961199 · Harry J. Bosworth Co. · Dental device
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Jun 1996
Decision
90d
Days
Class 2
Risk

K961199 is an FDA 510(k) clearance for the BOSWORTH TEMPORARY RESIN. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on June 25, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 K961199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1996
Decision Date June 25, 1996
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 88
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K961199.
3M QUIKPLUS SYSTEM
K970168 · 3M Company · Feb 1997
TEMPFIL C&B
K964981 · Sybron Dental Specialties, Inc. · Feb 1997
TEMPFIL F
K963786 · Sybron Dental Specialties, Inc. · Nov 1996
BELLEGLASHP
K955331 · Sybron Dental Specialties, Inc. · Jan 1996
3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
K944981 · 3M Company · Dec 1994
GC PATTERN RESIN
K942670 · GC America, Inc. · Oct 1994