Cleared Traditional

K082744 - BEAUTIBOND

K082744 is an FDA 510(k) clearance for BEAUTIBOND, manufactured by Shofu Dental Corp.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K082744 · Shofu Dental Corp. · Dental device
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Dec 2008
Decision
84d
Days
Class 2
Risk

K082744 is an FDA 510(k) clearance for the BEAUTIBOND. 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 December 11, 2008 after a review of 84 days - a notably fast clearance cycle.

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: 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 Shofu Dental Corp. devices

FDA 510(k) Submission Details - K082744

510(k) Number K082744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2008
Decision Date December 11, 2008
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 353
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K082744.
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
K091300 · CAO Group, Inc. · Jul 2009
ADHESE ONE F
K090941 · Ivoclar Vivadent, Inc. · Jul 2009
MONOBOND PLUS
K090826 · Ivoclar Vivadent, Inc. · May 2009
FUTURABOND M/FUTURABOND M SINGLE DOSE
K082753 · Voco GmbH · Nov 2008
G-BOND PLUS
K082768 · GC America, Inc. · Oct 2008
RELIANCE S.E.P.
K071688 · Reliance Orthodontic Products, Inc. · Sep 2007