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510(k) K231827

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments by B.T.I. Biotechnology Institute, Sl. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2023
Date Received
June 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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

  • K240262 — BTI Interna 3.0 Dental Implant System UnicCa® (October 10, 2024)
  • K232750 — BTI Interna Prosthetic Components (December 8, 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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