Cleared Traditional

K020256 - UNICEM

K020256 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 60-day FDA review.

K020256 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
60d
Days
Class 2
Risk

K020256 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 March 25, 2002 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Espe AG Dental Products devices

FDA 510(k) Submission Details - K020256

510(k) Number K020256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2002
Decision Date March 25, 2002
Days to Decision 60 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
67d faster than avg
Panel avg: 127d · This submission: 60d
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 K020256.
RELYX RMGIP
K022476 · 3M Company · Aug 2002
GC ELITE CEMENT 100
K021038 · GC America, Inc. · May 2002
PULPDENT POST CEMENT
K020481 · Pulpdent Corporation · Apr 2002
GC FUJI LINING LC PASTE PAK
K020117 · GC America, Inc. · Feb 2002
SCI-PHARM POST SECURE
K013555 · Scientific Pharmaceuticals, Inc. · Jan 2002
NEXUS 2 CLEAR
K013609 · Sybron Dental Specialties, Inc. · Jan 2002