Cleared Traditional

K102252 - DMP PIT & FISSURE SEALANT

K102252 is an FDA 510(k) clearance for DMP PIT & FISSURE SEALANT, manufactured by Dmp, Ltd.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K102252 · Dmp, Ltd. · Dental device
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Dec 2010
Decision
115d
Days
Class 2
Risk

K102252 is an FDA 510(k) clearance for the DMP PIT & FISSURE SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Dmp, Ltd. (Markopoulo, Attiki, GR). The FDA issued a Cleared decision on December 3, 2010 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 - K102252

510(k) Number K102252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2010
Decision Date December 03, 2010
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 95
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K102252.
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
K113818 · Pulpdent Corporation · Mar 2012
ULTRASEAL XT HYDRO
K112517 · Ultradent Products, Inc. · Sep 2011
BEAUTISEALANT
K111782 · Shofu Dental Corporation · Sep 2011
ECO-S
K103121 · Vericom Co., Ltd. · Oct 2010
ULTRASEAL ID
K101245 · Ultradent Products, Inc. · Sep 2010
INFILTRATION KIT
K100062 · Dmg USA, Inc. · Mar 2010