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FDA 510(k)

ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.

K-Number: K902078 · 1990-08-03

ApplicantCrx Medical, Inc.
Decision Date1990-08-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY. 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 1990-08-03 under 510(k) number K902078. 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 ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.?

ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY. is a medical device that received FDA 510(k) clearance on 1990-08-03. The listed applicant is Crx Medical, Inc.. The 510(k) number is K902078.

When did ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY. receive FDA 510(k) clearance?

ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY. received FDA 510(k) clearance on 1990-08-03, under 510(k) number K902078.

Who is the listed applicant for ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.?

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 ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.?

The FDA product code for ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY. is EMA.

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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.

K884652OCTYLDENT

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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