Cleared Traditional

K953119 - BOSWORTH RESIN II

K953119 is the FDA 510(k) clearance for BOSWORTH RESIN II by Bosworth Co.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K953119 · Bosworth Co. · Dental device
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Aug 1995
Decision
56d
Days
Class 2
Risk

K953119 is an FDA 510(k) clearance for the BOSWORTH RESIN II. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 56 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 Bosworth Co. devices

Submission Details

510(k) Number K953119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date August 28, 1995
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
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 153
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K953119.
CONNECT
K954689 · Sybron Dental Specialties, Inc. · Oct 1995
PALASPLINT
K953743 · Heraeus Kulzer, Inc. · Oct 1995
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
HARRY J. BOSWORTH RESIN I.
K946317 · Harry J. Bosworth Co. · Feb 1995