Cleared Traditional

K061611 - BOSWORTH DENTIN RESIN

K061611 is an FDA 510(k) clearance for BOSWORTH DENTIN RESIN, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K061611

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.

KLE Device Classification - Class 2, Special Controls

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 363
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K061611.
ADHESIVE DC ACTIVATOR
K062713 · Ivoclar Vivadent, Inc. · Nov 2006
PREMIER SELF-ETCHING BOND ENHANCER
K061998 · Premier Dental Products Co. · Oct 2006
CLEARFIL DC BOND
K062382 · Kuraray Medical, Inc. · Sep 2006
EXCEL BOND DC, MODEL 28-200100
K060882 · J. Morita USA, Inc. · Sep 2006
PORCELAIN PRIMER
K061322 · J. Morita USA, Inc. · Jun 2006
ADPER PROMPT, ADPER PROMPT L-POP
K060684 · 3M Espe AG Dental Products · Apr 2006