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FDA 510(k)

BTI Dental Implant System UnicCa

K-Number: K173257 · 2018-08-17

ApplicantB.T.I. Biotechnology Institute, Sl.
Decision Date2018-08-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BTI Dental Implant System UnicCa is the device name listed in this FDA 510(k) record. The listed applicant is B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K173257. 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 BTI Dental Implant System UnicCa?

BTI Dental Implant System UnicCa is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K173257.

When did BTI Dental Implant System UnicCa receive FDA 510(k) clearance?

BTI Dental Implant System UnicCa received FDA 510(k) clearance on 2018-08-17, under 510(k) number K173257.

Who is the listed applicant for BTI Dental Implant System UnicCa?

The FDA 510(k) record lists B.T.I. Biotechnology Institute, Sl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTI Dental Implant System UnicCa?

The FDA product code for BTI Dental Implant System UnicCa is DZE.

Other records listing B.T.I. Biotechnology Institute, Sl. as applicant

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K240262BTI Interna 3.0 Dental Implant System UnicCa®K232750BTI Interna Prosthetic ComponentsK231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsK213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsK211952BTI Interna Narrow/Plus Dental Implant System UnicCaK202825BTI Extra-Short Dental Implant System UnicCa

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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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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