Cleared Traditional

K023079 - NEW OUTLINE

K023079 is an FDA 510(k) clearance for NEW OUTLINE, manufactured by Anaxdent GmbH. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K023079 · Anaxdent GmbH · Dental device
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Oct 2002
Decision
44d
Days
Class 2
Risk

K023079 is an FDA 510(k) clearance for the NEW OUTLINE. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Anaxdent GmbH (Washington, US). The FDA issued a Cleared decision on October 30, 2002 after a review of 44 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 Anaxdent GmbH devices

FDA 510(k) Submission Details - K023079

510(k) Number K023079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2002
Decision Date October 30, 2002
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 127d · This submission: 44d
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 123
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K023079.
LEXATITE QUICK ACRYLIC
K033432 · Imtec Corp. · Jan 2004
PROTEMP 3 GARANT
K033022 · 3M Espe AG Dental Products · Nov 2003
FILL-IN
K031476 · Sybron Dental Specialties, Inc. · Jul 2003
SR IVOCRON
K013869 · Ivoclar Vivadent, Inc. · Aug 2002
BELLEGLASS HP MODELING GEL
K020178 · Kerr Dental Materials Center · Mar 2002
TEMPORARY CROWN AND BRIDGE MATERIAL
K020157 · J. Morita USA, Inc. · Mar 2002