Cleared Traditional

K961198 - BOSWORTH CH I

K961198 is an FDA 510(k) clearance for BOSWORTH CH I, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K961198 · Harry J. Bosworth Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
58d
Days
Class 2
Risk

K961198 is an FDA 510(k) clearance for the BOSWORTH CH I. 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 May 24, 1996 after a review of 58 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K961198

510(k) Number K961198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1996
Decision Date May 24, 1996
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

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 138
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K961198.
TCB TEMPORARY CROWN AND BRIDGE MATERIAL
K964691 · Scican · Feb 1997
TEMPFIL F
K963786 · Sybron Dental Specialties, Inc. · Nov 1996
BOSWORTH TEMPORARY RESIN
K961199 · Harry J. Bosworth Co. · Jun 1996
POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)
K954976 · Healex Products, Inc. · Apr 1996
PROV-KB
K960938 · Silicon-Und Composite Spezialitaten GmbH · Apr 1996
ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL
K960122 · Wallace A. Erickson & Co. · Feb 1996