Cleared Traditional

K020092 - TEMPHASE

K020092 is an FDA 510(k) clearance for TEMPHASE, manufactured by Kerr Dental Materials Center. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K020092 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
43d
Days
Class 2
Risk

K020092 is an FDA 510(k) clearance for the TEMPHASE. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Kerr Dental Materials Center (Orange, US). The FDA issued a Cleared decision on February 22, 2002 after a review of 43 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 Kerr Dental Materials Center devices

FDA 510(k) Submission Details - K020092

510(k) Number K020092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2002
Decision Date February 22, 2002
Days to Decision 43 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
84d faster than avg
Panel avg: 127d · This submission: 43d
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 122
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K020092.
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
TEMPFIL
K013895 · Sybron Dental Specialties, Inc. · Feb 2002
LUXATEMP/LUXATEMP SOLAR/INSTATEMP
K013674 · Dmg USA, Inc. · Jan 2002
LC TEMPORARY FILLING
K012360 · Parkell, Inc. · Sep 2001