Cleared Special

K052235 - LCR

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

K052235 · 3M Company · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K052235

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
87d faster than avg
Panel avg: 128d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

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 505
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K052235.
GI DENTSTAT
K060334 · Ultradent Products, Inc. · Feb 2006
TEMPBOND CLEAR WITH TRICLOSAN
K053565 · Sybron Dental Specialties, Inc. · Feb 2006
PARACEM UNIVERSAL DC
K053040 · Coltene/Whaledent AG · Nov 2005
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
K052235 · LCR
Download PDF FDA Summary 3M Company