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FDA 510(k)

DENTALEEN

K-Number: K791160 · 1980-02-21

ApplicantDenpac Corp.
Decision Date1980-02-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTALEEN is the device name listed in this FDA 510(k) record. The listed applicant is Denpac Corp.. It received FDA 510(k) clearance on 1980-02-21 under 510(k) number K791160. 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 DENTALEEN?

DENTALEEN is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Denpac Corp.. The 510(k) number is K791160.

When did DENTALEEN receive FDA 510(k) clearance?

DENTALEEN received FDA 510(k) clearance on 1980-02-21, under 510(k) number K791160.

Who is the listed applicant for DENTALEEN?

The FDA 510(k) record lists Denpac Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTALEEN?

The FDA product code for DENTALEEN is EMA.

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Other records listing Denpac Corp. 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.

K873373SINTERLOYK831484COMPOSI-GLAZEK831483SAVE-A-BAKE PORCELAIN POLISH

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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