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FDA 510(k)

BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS

K-Number: K061383 · 2006-08-03

ApplicantB.T.I. Biotechnology Institute, Sl.
Decision Date2006-08-03
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS 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 2006-08-03 under 510(k) number K061383. The device is classified under product code EJL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS?

BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS is a medical device that received FDA 510(k) clearance on 2006-08-03. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K061383.

When did BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS receive FDA 510(k) clearance?

BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS received FDA 510(k) clearance on 2006-08-03, under 510(k) number K061383.

Who is the listed applicant for BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS?

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 STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS?

The FDA product code for BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS is EJL.

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Related Devices (Code: EJL)

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.

K080687SMARTBURSS.S. White Burs, Inc.K071352CERADRILLGebr. Brasseler GmbH & Co. KGK943273TRI HAWK BUR, FG BURTri Hawk Corp.K926205MONOSTERYLUtensili Super AbrasiviK923883DENTAL OR SURGICAL BURStratum Dental Technologies, Inc.K921406SILICONT BUR BLOCKInnovators, 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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