Cleared Traditional

K946317 - HARRY J. BOSWORTH RESIN I.

K946317 is an FDA 510(k) clearance for HARRY J. BOSWORTH RESIN I., 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 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.

FDA 510(k) Submission Details - K946317

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 128d · This submission: 50d
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 324
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K946317.
PRECISE DENTURE BASE RESIN
K952351 · Dentsply Intl. · Jul 1995
SEALDENT
K944466 · Scientific Pharmaceuticals, Inc. · Mar 1995
PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER
K943905 · Professional Positioners, Inc. · Feb 1995
EXCEL-P FORMULA AUTO-CURE DENTURE BASE
K945711 · St. George Technology, Inc. · Feb 1995
PROSTHOFLEX
K942562 · Knopf Assoc, Inc. · Dec 1994
ORTHO-JET ACRYLIC RESIN - SPARKLE
K941925 · Lang Dental Mfg. Co., Inc. · May 1994
K946317 · HARRY J. BOSWORTH RESIN I.
Download PDF Harry J. Bosworth Co.