Cleared Traditional

K000357 - EZ CONNECT RESIN

K000357 is an FDA 510(k) clearance for EZ CONNECT RESIN, manufactured by Kerr Dental Materials Center. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K000357 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
84d
Days
Class 2
Risk

K000357 is an FDA 510(k) clearance for the EZ CONNECT RESIN. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kerr Dental Materials Center (Orange, US). The FDA issued a Cleared decision on April 28, 2000 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K000357

510(k) Number K000357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date April 28, 2000
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 709
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K000357.
GRADIA
K001518 · GC America, Inc. · Jul 2000
SIGNUM
K001360 · J.F. Jelenko & Co., Inc. · Jun 2000
BELLEGLASS HP ENAMEL
K000530 · Sybron Dental Specialties, Inc. · May 2000
BELLEGLASS HP TRANSLUCENT DENTIN
K000436 · Sybron Dental Specialties, Inc. · Mar 2000
BELLEGLASS HP OPACEOUS DENTIN
K000269 · Sybron Dental Specialties, Inc. · Mar 2000
BUILD-IT FR
K000211 · Jeneric/Pentron, Inc. · Mar 2000