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FDA 510(k)

CARMEN

K-Number: K011425 · 2001-06-05

ApplicantDentaurum, Inc.
Decision Date2001-06-05
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARMEN is the device name listed in this FDA 510(k) record. The listed applicant is Dentaurum, Inc.. It received FDA 510(k) clearance on 2001-06-05 under 510(k) number K011425. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARMEN?

CARMEN is a medical device that received FDA 510(k) clearance on 2001-06-05. The listed applicant is Dentaurum, Inc.. The 510(k) number is K011425.

When did CARMEN receive FDA 510(k) clearance?

CARMEN received FDA 510(k) clearance on 2001-06-05, under 510(k) number K011425.

Who is the listed applicant for CARMEN?

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

What is the FDA product code for CARMEN?

The FDA product code for CARMEN is EIH.

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Other records listing Dentaurum, 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.

K042965TOMAS PINK011428TRICERAM

Related Devices (Code: EIH)

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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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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