DENTALIS KEZ ENDODONITC SEALER— 510(k) K971642

Name: FDA 510(k) clearance K971642
Creator: U.S. Food and Drug Administration
Published: 1997-07-24

Substantially Equivalent

Neodental Chemical Products Co., Ltd.

FDA 510(k) clearance K971642 for DENTALIS KEZ ENDODONITC SEALER, Substantially Equivalent on 1997-07-24. Applicant: Neodental Chemical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Neodental Chemical Products Co., Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1997-05-02
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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