Cleared Traditional

K973667 - VITAPEX PRE-LOADED DENTAL SYRINGE

K973667 is an FDA 510(k) clearance for VITAPEX PRE-LOADED DENTAL SYRINGE, manufactured by Neodental Chemical Products Co., Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K973667 · Neodental Chemical Products Co., Ltd. · Dental device
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Nov 1997
Decision
42d
Days
Class 2
Risk

K973667 is an FDA 510(k) clearance for the VITAPEX PRE-LOADED DENTAL SYRINGE. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Neodental Chemical Products Co., Ltd. (Bethesda, US). The FDA issued a Cleared decision on November 6, 1997 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Neodental Chemical Products Co., Ltd. devices

FDA 510(k) Submission Details - K973667

510(k) Number K973667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1997
Decision Date November 06, 1997
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
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.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 94
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K973667.
MTA MATERIAL II
K981620 · Dentsply Intl. · Jul 1998
ENDOSOLV E
K980633 · Specialites Septodont · May 1998
MTA MATERIAL
K980332 · Dentsply Intl. · Feb 1998
SEALAPEX
K972369 · Sybron Dental Specialties, Inc. · Aug 1997
ENDO-SEAL
K971899 · Ultradent Products, Inc. · Jun 1997
ALPHA-DENT ROOT CANAL SEALER & FILLER
K963922 · Wallace A. Erickson & Co. · Dec 1996