Cleared Traditional

K033022 - PROTEMP 3 GARANT

K033022 is an FDA 510(k) clearance for PROTEMP 3 GARANT, 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 57-day FDA review.

K033022 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
57d
Days
Class 2
Risk

K033022 is an FDA 510(k) clearance for the PROTEMP 3 GARANT. 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 November 21, 2003 after a review of 57 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 - K033022

510(k) Number K033022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2003
Decision Date November 21, 2003
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
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 K033022.
STRUCTUR 2 SC
K040769 · Voco GmbH · Apr 2004
LUXAFORM PLUS
K033227 · Dmg USA, Inc. · Jan 2004
LEXATITE QUICK ACRYLIC
K033432 · Imtec Corp. · Jan 2004
FILL-IN
K031476 · Sybron Dental Specialties, Inc. · Jul 2003
SR IVOCRON
K013869 · Ivoclar Vivadent, Inc. · Aug 2002
TEMPORARY CROWN AND BRIDGE MATERIAL
K020157 · J. Morita USA, Inc. · Mar 2002