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FDA 510(k)

ORTHOCENT: LIQUID AND POWDER

K-Number: K942665 · 1994-07-22

ApplicantDentauraum, Inc.
Decision Date1994-07-22
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOCENT: LIQUID AND POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Dentauraum, Inc.. It received FDA 510(k) clearance on 1994-07-22 under 510(k) number K942665. 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 ORTHOCENT: LIQUID AND POWDER?

ORTHOCENT: LIQUID AND POWDER is a medical device that received FDA 510(k) clearance on 1994-07-22. The listed applicant is Dentauraum, Inc.. The 510(k) number is K942665.

When did ORTHOCENT: LIQUID AND POWDER receive FDA 510(k) clearance?

ORTHOCENT: LIQUID AND POWDER received FDA 510(k) clearance on 1994-07-22, under 510(k) number K942665.

Who is the listed applicant for ORTHOCENT: LIQUID AND POWDER?

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

What is the FDA product code for ORTHOCENT: LIQUID AND POWDER?

The FDA product code for ORTHOCENT: LIQUID AND POWDER is EMA.

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Other records listing Dentauraum, 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.

K952867REMANIUM:GM 700, GM 380, GM 800, GFHK952866REMATITAN TITANIUMK952870REMANIUM: CS & G-SOFTK952865REMANIUM: 200,CS, 380, AND CDK952868DENTAURUM JACKET CROWN & ROOT POSTSK942667DENT-O-CRYL ORTHODONTIC ACRYLIC

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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

View on FDA Database →

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

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