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FDA 510(k)

OCTYLDENT

K-Number: K884652 · 1989-05-24

ApplicantCrx Medical, Inc.
Decision Date1989-05-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OCTYLDENT is the device name listed in this FDA 510(k) record. The listed applicant is Crx Medical, Inc.. It received FDA 510(k) clearance on 1989-05-24 under 510(k) number K884652. 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 OCTYLDENT?

OCTYLDENT is a medical device that received FDA 510(k) clearance on 1989-05-24. The listed applicant is Crx Medical, Inc.. The 510(k) number is K884652.

When did OCTYLDENT receive FDA 510(k) clearance?

OCTYLDENT received FDA 510(k) clearance on 1989-05-24, under 510(k) number K884652.

Who is the listed applicant for OCTYLDENT?

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

What is the FDA product code for OCTYLDENT?

The FDA product code for OCTYLDENT is EMA.

Related Clinical Trials

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.

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Other records listing Crx Medical, 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.

K902078ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.

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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