Cleared Traditional

K961200 - BOSWORTH LIQUID RESIN II

K961200 is the FDA 510(k) clearance for BOSWORTH LIQUID RESIN II by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K961200 · Harry J. Bosworth Co. · Dental device
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May 1996
Decision
51d
Days
Class 2
Risk

K961200 is an FDA 510(k) clearance for the BOSWORTH LIQUID RESIN II. 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 May 17, 1996 after a review of 51 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 K961200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1996
Decision Date May 17, 1996
Days to Decision 51 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
76d faster than avg
Panel avg: 127d · This submission: 51d
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 K961200.
SOFT DENTURE REBASING RESIN
K963736 · Sybron Dental Specialties, Inc. · Dec 1996
GC BASELINE
K963144 · GC America, Inc. · Oct 1996
QUICKSPLINT
K961995 · Heraeus Kulzer, Inc. · Jun 1996
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