Cleared Traditional

K955703 - NEO DENTAL ENDODONTIC IRRIGATION SYRINGE

K955703 is an FDA 510(k) clearance for NEO DENTAL ENDODONTIC IRRIGATION 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 158-day FDA review.

K955703 · Neodental Chemical Products Co., Ltd. · Dental device
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May 1996
Decision
158d
Days
Class 2
Risk

K955703 is an FDA 510(k) clearance for the NEO DENTAL ENDODONTIC IRRIGATION 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 May 20, 1996 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Neodental Chemical Products Co., Ltd. devices

FDA 510(k) Submission Details - K955703

510(k) Number K955703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1995
Decision Date May 20, 1996
Days to Decision 158 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
31d slower than avg
Panel avg: 127d · This submission: 158d
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 K955703.
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
AH PLUS ROOT CANAL SEALER
K960548 · Dentsply Intl. · Apr 1996
CANAL KING (THIN) CANAL KING (THICK)
K940368 · Pulpdent Corp. · Jan 1995
PULPDENT ROOT CANAL SEALER
K946138 · Pulpdent Corp. · Jan 1995