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510(k) K202344

TiUltra Implants and Xeal Abutments by Nobel Biocare AB — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2020
Date Received
August 18, 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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