Cleared Abbreviated

K093338 - SELF ADHESIVE COMPOSITE LUTING CEMENT

K093338 is an FDA 510(k) clearance for SELF ADHESIVE COMPOSITE LUTING CEMENT, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Abbreviated 510(k) pathway after a 112-day FDA review.

K093338 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
112d
Days
Class 2
Risk

K093338 is an FDA 510(k) clearance for the SELF ADHESIVE COMPOSITE LUTING CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on February 12, 2010 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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.

View all Dmg USA, Inc. devices

FDA 510(k) Submission Details - K093338

510(k) Number K093338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2009
Decision Date February 12, 2010
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Standards-based clearance path.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 349
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