Cleared Traditional

K021457 - FLEX SPAN TEMPORARY CROWN & BRIDGE MATE...

K021457 is the FDA 510(k) clearance for FLEX SPAN TEMPORARY CROWN & BRIDGE MATE... by Pentron Corp.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K021457 · Pentron Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
87d
Days
Class 2
Risk

K021457 is an FDA 510(k) clearance for the FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Pentron Corp. (Wallingford, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 87 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 Pentron Corp. devices

Submission Details

510(k) Number K021457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2002
Decision Date August 01, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K021457.
STRUCTUR 2 SC
K040769 · Voco GmbH · Apr 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
TEMPFIL
K013895 · Sybron Dental Specialties, Inc. · Feb 2002
LC TEMPORARY FILLING
K012360 · Parkell, Inc. · Sep 2001