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510(k) K240262

BTI Interna 3.0 Dental Implant System UnicCa® by B.T.I. Biotechnology Institute, Sl. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2024
Date Received
January 31, 2024
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.

  • K232750 — BTI Interna Prosthetic Components (December 8, 2023)
  • K231827 — BTI Dental Implant System UnicCa® – Aesthetic Post Abutments (September 15, 2023)
  • K213106 — BTI Interna Dental Implant System UnicCa - Prosthetic Components (October 20, 2022)
  • K211952 — BTI Interna Narrow/Plus Dental Implant System UnicCa (July 21, 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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