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FDA 510(k)

DENTALIS KEZ ENDODONITC SEALER

K-Number: K971642 · 1997-07-24

ApplicantNeodental Chemical Products Co., Ltd.
Decision Date1997-07-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTALIS KEZ ENDODONITC SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Neodental Chemical Products Co., Ltd.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K971642. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTALIS KEZ ENDODONITC SEALER?

DENTALIS KEZ ENDODONITC SEALER is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Neodental Chemical Products Co., Ltd.. The 510(k) number is K971642.

When did DENTALIS KEZ ENDODONITC SEALER receive FDA 510(k) clearance?

DENTALIS KEZ ENDODONITC SEALER received FDA 510(k) clearance on 1997-07-24, under 510(k) number K971642.

Who is the listed applicant for DENTALIS KEZ ENDODONITC SEALER?

The FDA 510(k) record lists Neodental Chemical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTALIS KEZ ENDODONITC SEALER?

The FDA product code for DENTALIS KEZ ENDODONITC SEALER is EMA.

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Other records listing Neodental Chemical Products Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111666EVADYNE TEMPORARY CROWN AND BRIDGE RESINK111668CAVIOS CAVITY LINERK973667VITAPEX PRE-LOADED DENTAL SYRINGEK955703NEO DENTAL ENDODONTIC IRRIGATION SYRINGE

Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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