Cleared Special

K052235 - LCR

K052235 is the FDA 510(k) clearance for LCR by 3M Company. It is a Class 2 Dental device (product code EMA) cleared through the Special 510(k) pathway after a 41-day FDA review.

K052235 · 3M Company · Dental device
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Sep 2005
Decision
41d
Days
Class 2
Risk

K052235 is an FDA 510(k) clearance for the LCR. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on September 27, 2005 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K052235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2005
Decision Date September 27, 2005
Days to Decision 41 days
Submission Type Special
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
86d faster than avg
Panel avg: 127d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K052235.
BIFIX QM
K060894 · Voco GmbH · May 2006
GI DENTSTAT
K060334 · Ultradent Products, Inc. · Feb 2006
TEMPBOND CLEAR WITH TRICLOSAN
K053565 · Sybron Dental Specialties, Inc. · Feb 2006
EUGENONE
K051952 · Scientific Pharmaceuticals, Inc. · Sep 2005
PREMIER TEMPORARY CEMENT
K051866 · Premier Dental Products Co. · Sep 2005
GC FUJI FIL LC
K051427 · GC America, Inc. · Aug 2005