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FDA 510(k)

BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI

K-Number: K083869 · 2009-03-27

ApplicantBtlock Srl
Decision Date2009-03-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI is the device name listed in this FDA 510(k) record. The listed applicant is Btlock Srl. It received FDA 510(k) clearance on 2009-03-27 under 510(k) number K083869. 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 BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI?

BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI is a medical device that received FDA 510(k) clearance on 2009-03-27. The listed applicant is Btlock Srl. The 510(k) number is K083869.

When did BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI receive FDA 510(k) clearance?

BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI received FDA 510(k) clearance on 2009-03-27, under 510(k) number K083869.

Who is the listed applicant for BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI?

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

What is the FDA product code for BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI?

The FDA product code for BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI 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 Btlock Srl 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.

K073458BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)

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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