Cleared Abbreviated

K082700 - TEMPORARY COLD.V AND SELF-CURE DENTINE

K082700 is an FDA 510(k) clearance for TEMPORARY COLD.V AND SELF-CURE DENTINE, manufactured by Major Prodotti Dentari S.P.A.. The device is a Class 2 Dental device with product code EBG cleared through the Abbreviated 510(k) pathway after a 85-day FDA review.

K082700 · Major Prodotti Dentari S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
85d
Days
Class 2
Risk

K082700 is an FDA 510(k) clearance for the TEMPORARY COLD.V AND SELF-CURE DENTINE. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Major Prodotti Dentari S.P.A. (Monacalieri (Torino), IT). The FDA issued a Cleared decision on December 9, 2008 after a review of 85 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Major Prodotti Dentari S.P.A. devices

FDA 510(k) Submission Details - K082700

510(k) Number K082700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date December 09, 2008
Days to Decision 85 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

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 125
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K082700.
LUXATEMP ULTRA /STAR
K101710 · Dmg USA, Inc. · Sep 2010
TELIO CAD
K093708 · Ivoclar Vivadent, Inc. · Mar 2010
TEMPORARY C&B COMPOSITE
K091894 · Voco GmbH · Jul 2009
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL
K081810 · Pulpdent Corporation · Sep 2008
UNIFAST III
K073106 · GC America, Inc. · Apr 2008
ZENO PMMA DISC
K080182 · Wieland Dental + Technik GmbH & Co. KG · Apr 2008