Cleared Traditional

K941373 - PENT CORE PLUS (PASTE-PASTE)

K941373 is an FDA 510(k) clearance for PENT CORE PLUS (PASTE-PASTE), 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 42-day FDA review.

K941373 · Jeneric/Pentron, Inc. · Dental device
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May 1994
Decision
42d
Days
Class 2
Risk

K941373 is an FDA 510(k) clearance for the PENT CORE PLUS (PASTE-PASTE). 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 May 3, 1994 after a review of 42 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 - K941373

510(k) Number K941373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1994
Decision Date May 03, 1994
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
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 K941373.
HERCULITE XR & XRV
K943642 · Sybron Dental Specialties, Inc. · Nov 1994
ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN
K942767 · Wallace A. Erickson & Co. · Jul 1994
CAULK TOOTH CONDITIONER GEL AND SYRINGE
K942031 · Dentsply Intl. · Jun 1994
CONQUEST SMOOTH TOUCH
K941377 · Jeneric/Pentron, Inc. · May 1994
CONQUEST PRELUDE
K941374 · Jeneric/Pentron, Inc. · May 1994
CONQUEST GINGA-BLEND
K941375 · Jeneric/Pentron, Inc. · May 1994