Cleared Traditional

K971642 - DENTALIS KEZ ENDODONITC SEALER

K971642 is an FDA 510(k) clearance for DENTALIS KEZ ENDODONITC SEALER, manufactured by Neodental Chemical Products Co., Ltd.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K971642 · Neodental Chemical Products Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
83d
Days
Class 2
Risk

K971642 is an FDA 510(k) clearance for the DENTALIS KEZ ENDODONITC SEALER. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Neodental Chemical Products Co., Ltd. (Bethesda, US). The FDA issued a Cleared decision on July 24, 1997 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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.

FDA 510(k) Submission Details - K971642

510(k) Number K971642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1997
Decision Date July 24, 1997
Days to Decision 83 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
45d faster than avg
Panel avg: 128d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 470
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K971642.
TEMP BOND CLEAR
K972844 · Kerr Dental Materials Center · Oct 1997
PULPDENT OX-OUT
K972445 · Pulpdent Corp. · Oct 1997
CIMPAT N
K972485 · Arent, Fox, Kintner, Plotkin & Kahn · Sep 1997
HI DENSE TC
K971927 · Shofu Dental Corp. · Jun 1997
TEMPOCEM NE (MULTIPLE)
K970774 · Foremost Dental Mfg., Inc. · Jun 1997
TEMPO CEM (MULTIPLE)
K970775 · Foremost Dental Mfg., Inc. · Jun 1997
K971642 · DENTALIS KEZ ENDODONITC SEALER
Download PDF Neodental Chemical Pr…