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510(k) K202825

BTI Extra-Short Dental Implant System UnicCa by B.T.I. Biotechnology Institute, Sl. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2021
Date Received
September 24, 2020
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

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  • K070533 — BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS (June 21, 2007)

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