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FDA 510(k)

BTI Extra-Short Dental Implant System UnicCa

K-Number: K202825 · 2021-07-29

ApplicantB.T.I. Biotechnology Institute, Sl.
Decision Date2021-07-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BTI Extra-Short 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 2021-07-29 under 510(k) number K202825. 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 Extra-Short Dental Implant System UnicCa?

BTI Extra-Short Dental Implant System UnicCa is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K202825.

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

BTI Extra-Short Dental Implant System UnicCa received FDA 510(k) clearance on 2021-07-29, under 510(k) number K202825.

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

The FDA product code for BTI Extra-Short Dental Implant System UnicCa 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.

NCT04237545A Clinical Study of the T3 Short Dental Implant SystemCOMPLETEDNCT06355713Improvement of Symptoms After Removal of the Essure® Contraceptive ImplantRECRUITINGNCT06849856Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment ApproachesCOMPLETEDNCT07498556Immediate Restoration of a New Implant With High Primary StabilityNOT_YET_RECRUITINGNCT07791082Clinical Success of 12 mm Needle IANB in ChildrenRECRUITING

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

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 UnicCaK173257BTI Dental Implant System UnicCa

View all 8 devices →

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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