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FDA 510(k)

DENTEMP ONE STEP

K-Number: K964773 · 1997-02-21

ApplicantMajestic Drug Co., Inc.
Decision Date1997-02-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTEMP ONE STEP is the device name listed in this FDA 510(k) record. The listed applicant is Majestic Drug Co., Inc.. It received FDA 510(k) clearance on 1997-02-21 under 510(k) number K964773. 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 DENTEMP ONE STEP?

DENTEMP ONE STEP is a medical device that received FDA 510(k) clearance on 1997-02-21. The listed applicant is Majestic Drug Co., Inc.. The 510(k) number is K964773.

When did DENTEMP ONE STEP receive FDA 510(k) clearance?

DENTEMP ONE STEP received FDA 510(k) clearance on 1997-02-21, under 510(k) number K964773.

Who is the listed applicant for DENTEMP ONE STEP?

The FDA 510(k) record lists Majestic Drug Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTEMP ONE STEP?

The FDA product code for DENTEMP ONE STEP is EMA.

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Other records listing Majestic Drug Co., Inc. 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.

K101771RELINE-IT MODEL RELINE-ITK821581DEN TEMP

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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