Cleared Traditional

K110235 - BEAUTIBOND MULTI

K110235 is the FDA 510(k) clearance for BEAUTIBOND MULTI by Shofu Dental Corp.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K110235 · Shofu Dental Corp. · Dental device
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May 2011
Decision
107d
Days
Class 2
Risk

K110235 is an FDA 510(k) clearance for the BEAUTIBOND MULTI. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Shofu Dental Corp. (San Marcos, US). The FDA issued a Cleared decision on May 13, 2011 after a review of 107 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 Shofu Dental Corp. devices

Submission Details

510(k) Number K110235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2011
Decision Date May 13, 2011
Days to Decision 107 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
20d faster than avg
Panel avg: 127d · This submission: 107d
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 220
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K110235.
PEAK Z
K131357 · Ultradent Products, Inc. · Sep 2013
FUTURABOND UNIVERSAL
K130486 · Voco GmbH · Jun 2013
DREAMBOND
K112118 · Bisco, Inc. · Nov 2011
BEAUTIBOND MULTI PR PLUS
K110252 · Shofu Dental Corp. · May 2011
ALL-BOUND 3
K102844 · Bisco, Inc. · Oct 2010
ALL-ETCH, ALL- ETCH WITH BAC
K101485 · Bisco, Inc. · Aug 2010