Cleared Traditional

K061611 - BOSWORTH DENTIN RESIN

K061611 is the FDA 510(k) clearance for BOSWORTH DENTIN RESIN by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K061611 · Harry J. Bosworth Co. · Dental device
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Sep 2006
Decision
94d
Days
Class 2
Risk

K061611 is an FDA 510(k) clearance for the BOSWORTH DENTIN RESIN. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on September 11, 2006 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Harry J. Bosworth Co. devices

Submission Details

510(k) Number K061611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2006
Decision Date September 11, 2006
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 227
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K061611.
PEAK BOND, MODEL 5133
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ADHESIVE DC ACTIVATOR
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K060882 · J. Morita USA, Inc. · Sep 2006
PORCELAIN PRIMER
K061322 · J. Morita USA, Inc. · Jun 2006
OPTIBOND ALL-IN-ONE
K060469 · Sybron Dental Specialties, Inc. · Mar 2006