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510(k) K211952

BTI Interna Narrow/Plus Dental Implant System UnicCa by B.T.I. Biotechnology Institute, Sl. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2022
Date Received
June 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by B.T.I. Biotechnology Institute, Sl.

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  • K213106 — BTI Interna Dental Implant System UnicCa - Prosthetic Components (October 20, 2022)
  • K202825 — BTI Extra-Short Dental Implant System UnicCa (July 29, 2021)
  • K173257 — BTI Dental Implant System UnicCa (August 17, 2018)
  • K151391 — BTI Dental Implant System UnicCa (May 2, 2016)
  • K091387 — BTI DENTAL IMPLANT 5.5-6.5 (January 22, 2010)
  • K092112 — BTI DENTAL IMPLANT TINY 2.5-3.0 (October 6, 2009)
  • K070533 — BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS (June 21, 2007)

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