Cleared Traditional

K094007 - UNICEM

K094007 is an FDA 510(k) clearance for UNICEM, manufactured by 3M Espe AG Dental Products. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K094007 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
101d
Days
Class 2
Risk

K094007 is an FDA 510(k) clearance for the UNICEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on April 8, 2010 after a review of 101 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 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 3M Espe AG Dental Products devices

FDA 510(k) Submission Details - K094007

510(k) Number K094007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2009
Decision Date April 08, 2010
Days to Decision 101 days
Submission Type Traditional
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
26d faster than avg
Panel avg: 127d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 309
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K094007.
UNICEM HM
K100908 · 3M Espe AG Dental Products · Jun 2010
RETRIEVE IMPLANT CEMENT
K101044 · Parkell, Inc. · Jun 2010
MALTA
K100756 · 3M Espe AG Dental Products · Jun 2010
SELF ADHESIVE COMPOSITE LUTING CEMENT
K093338 · Dmg USA, Inc. · Feb 2010
IONOLUX
K090817 · Voco GmbH · Jul 2009
EQUIA
K091106 · GC America, Inc. · Jun 2009