Cleared Traditional

K073296 - TEMPXN28

K073296 is an FDA 510(k) clearance for TEMPXN28, manufactured by 3M Espe AG Dental Products. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K073296 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
47d
Days
Class 2
Risk

K073296 is an FDA 510(k) clearance for the TEMPXN28. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on January 9, 2008 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 - K073296

510(k) Number K073296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2007
Decision Date January 09, 2008
Days to Decision 47 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
80d faster than avg
Panel avg: 127d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 111
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K073296.
UNIFAST III
K073106 · GC America, Inc. · Apr 2008
ZENO PMMA DISC
K080182 · Wieland Dental + Technik GmbH & Co. KG · Apr 2008
PRO-V
K073263 · Bisco, Inc. · Feb 2008
TEMPFX ESTHETIC PROVISIONAL SYSTEM
K061264 · Dentsply International, Inc. · May 2006
TEMPORARY CROWN & BRIDGE RESIN
K060881 · Cosmedent, Inc. · May 2006
PROVISIONAL INLAY/ONLAY KIT
K052800 · Dmg USA, Inc. · Mar 2006