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FDA 510(k)

MODIFICATION OF PARAPOST CEMENT

K-Number: K993710 · 1999-12-21

ApplicantColtene/Whaledent, Inc.
Decision Date1999-12-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF PARAPOST CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K993710. 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 MODIFICATION OF PARAPOST CEMENT?

MODIFICATION OF PARAPOST CEMENT is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K993710.

When did MODIFICATION OF PARAPOST CEMENT receive FDA 510(k) clearance?

MODIFICATION OF PARAPOST CEMENT received FDA 510(k) clearance on 1999-12-21, under 510(k) number K993710.

Who is the listed applicant for MODIFICATION OF PARAPOST CEMENT?

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

What is the FDA product code for MODIFICATION OF PARAPOST CEMENT?

The FDA product code for MODIFICATION OF PARAPOST CEMENT is EMA.

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Other records listing Coltene/Whaledent, Inc. as applicant

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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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