Cleared Special

K002364 - PROTEMP H

K002364 is the FDA 510(k) clearance for PROTEMP H by Espe Dental AG. It is a Class 2 Dental device (product code EBG) cleared through the Special 510(k) pathway after a 7-day FDA review.

K002364 · Espe Dental AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
7d
Days
Class 2
Risk

K002364 is an FDA 510(k) clearance for the PROTEMP H. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Espe Dental AG (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on August 10, 2000 after a review of 7 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. 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.

View all Espe Dental AG devices

Submission Details

510(k) Number K002364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2000
Decision Date August 10, 2000
Days to Decision 7 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
120d faster than avg
Panel avg: 127d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 100
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K002364.
PATTERN RESIN
K003817 · GC America, Inc. · Jan 2001
FERMIT PLUS
K003374 · Ivoclar North America, Inc. · Dec 2000
FERMIT N PLUS
K003377 · Ivoclar North America, Inc. · Dec 2000
3M QUIK TEMP TEMPORIZATION MATERIAL
K001114 · 3M Company · Jun 2000
JELTEMP
K991564 · J.F. Jelenko & Co., Inc. · Jun 1999
SMARTEMP
K991270 · Parkell, Inc. · May 1999