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510(k) K212125

Nobel Biocare Dental Implant Systems Portfolio - MR Conditional by Nobel Biocare AG — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2021
Date Received
July 7, 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

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