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FDA 510(k)

T.B.R. ZIRCONNECT

K-Number: K070935 · 2007-11-09

ApplicantSudimplant SA
Decision Date2007-11-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

T.B.R. ZIRCONNECT is the device name listed in this FDA 510(k) record. The listed applicant is Sudimplant SA. It received FDA 510(k) clearance on 2007-11-09 under 510(k) number K070935. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T.B.R. ZIRCONNECT?

T.B.R. ZIRCONNECT is a medical device that received FDA 510(k) clearance on 2007-11-09. The listed applicant is Sudimplant SA. The 510(k) number is K070935.

When did T.B.R. ZIRCONNECT receive FDA 510(k) clearance?

T.B.R. ZIRCONNECT received FDA 510(k) clearance on 2007-11-09, under 510(k) number K070935.

Who is the listed applicant for T.B.R. ZIRCONNECT?

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

What is the FDA product code for T.B.R. ZIRCONNECT?

The FDA product code for T.B.R. ZIRCONNECT is DZE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sudimplant SA 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.

K050956TBR IDEA CONIC/CONIC

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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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