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FDA 510(k)

TRICERAM

K-Number: K011428 · 2001-06-05

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

Device Summary

TRICERAM 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 K011428. 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 TRICERAM?

TRICERAM 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 K011428.

When did TRICERAM receive FDA 510(k) clearance?

TRICERAM received FDA 510(k) clearance on 2001-06-05, under 510(k) number K011428.

Who is the listed applicant for TRICERAM?

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 TRICERAM?

The FDA product code for TRICERAM is EIH.

Related Clinical Trials

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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 PINK011425CARMEN

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

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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