Cleared Traditional

K102254 - DMP SINGLE BONDING

K102254 is an FDA 510(k) clearance for DMP SINGLE BONDING, manufactured by Dmp, Ltd.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K102254 · Dmp, Ltd. · Dental device
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Nov 2010
Decision
105d
Days
Class 2
Risk

K102254 is an FDA 510(k) clearance for the DMP SINGLE BONDING. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dmp, Ltd. (Markopoulo, Attiki, GR). The FDA issued a Cleared decision on November 23, 2010 after a review of 105 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 Dmp, Ltd. devices

FDA 510(k) Submission Details - K102254

510(k) Number K102254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2010
Decision Date November 23, 2010
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
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 343
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K102254.
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
K111975 · Kuraray Medical, Inc. · Oct 2011
BEAUTIBOND MULTI
K110235 · Shofu Dental Corp. · May 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
OPTIBOND XTR
K101423 · Kerr Corporation · Jul 2010