Cleared Traditional

K946317 - HARRY J. BOSWORTH RESIN I.

K946317 is the FDA 510(k) clearance for HARRY J. BOSWORTH RESIN I. by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K946317 · Harry J. Bosworth Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
50d
Days
Class 2
Risk

K946317 is an FDA 510(k) clearance for the HARRY J. BOSWORTH RESIN I.. 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 February 16, 1995 after a review of 50 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K946317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1994
Decision Date February 16, 1995
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
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 K946317.
PROP. CONQUEST C&B VLC GLAZE/SEALANT
K953381 · Jeneric/Pentron, Inc. · Sep 1995
PRECISE DENTURE BASE RESIN
K952351 · Dentsply Intl. · Jul 1995
SEALDENT
K944466 · Scientific Pharmaceuticals, Inc. · Mar 1995
COE-SOFT LC
K940565 · GC America, Inc. · May 1994
KOOLINER II
K935261 · GC America, Inc. · Jan 1994
REBARON LC
K930939 · GC America, Inc. · Jan 1994