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FDA 510(k)

BTI DENTAL IMPLANT 5.5-6.5

K-Number: K091387 · 2010-01-22

ApplicantB.T.I. Biotechnology Institute, Sl.
Decision Date2010-01-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BTI DENTAL IMPLANT 5.5-6.5 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 2010-01-22 under 510(k) number K091387. 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 5.5-6.5?

BTI DENTAL IMPLANT 5.5-6.5 is a medical device that received FDA 510(k) clearance on 2010-01-22. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K091387.

When did BTI DENTAL IMPLANT 5.5-6.5 receive FDA 510(k) clearance?

BTI DENTAL IMPLANT 5.5-6.5 received FDA 510(k) clearance on 2010-01-22, under 510(k) number K091387.

Who is the listed applicant for BTI DENTAL IMPLANT 5.5-6.5?

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 5.5-6.5?

The FDA product code for BTI DENTAL IMPLANT 5.5-6.5 is DZE.

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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.

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

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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