Cleared Traditional

K964578 - FIBREKOR

K964578 is an FDA 510(k) clearance for FIBREKOR, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K964578 · Jeneric/Pentron, Inc. · Dental device
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Dec 1996
Decision
18d
Days
Class 2
Risk

K964578 is an FDA 510(k) clearance for the FIBREKOR. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on December 3, 1996 after a review of 18 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K964578

510(k) Number K964578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1996
Decision Date December 03, 1996
Days to Decision 18 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 127d · This submission: 18d
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 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K964578.
WHITE CORE
K964931 · Bisco, Inc. · Feb 1997
ULTRA-ETCH STAT
K965060 · Ultradent Products, Inc. · Jan 1997
TETRIC CERAM
K964285 · Ivoclar North America, Inc. · Jan 1997
PRODIGY AC
K963805 · Sybron Dental Specialties, Inc. · Nov 1996
PULPDENT DESENSITIZER
K963652 · Pulpdent Corp. · Oct 1996
TEAM ETCH
K963311 · Centrix, Inc. · Oct 1996