Cleared Abbreviated

K102603 - SA FLOWABLE ADHESIVE

K102603 is an FDA 510(k) clearance for SA FLOWABLE ADHESIVE, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 68-day FDA review.

K102603 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
68d
Days
Class 2
Risk

K102603 is an FDA 510(k) clearance for the SA FLOWABLE ADHESIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on November 17, 2010 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K102603

510(k) Number K102603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2010
Decision Date November 17, 2010
Days to Decision 68 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 128d · This submission: 68d
Pathway characteristics
Standards-based clearance path.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 863
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K102603.
AURA
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NANOCERAM- BRIGHT
K102257 · Dmp, Ltd. · Nov 2010
GRANDIO SO HEAVY FLOW
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GRANDIO SO
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GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
K101540 · Novocol Inc. Dba Septodont and Confi-Dental Produc · Oct 2010