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510(k) K093615

SPI DENTAL IMPLANT, ELEMENT by Thommen Medical AG — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2010
Date Received
November 23, 2009
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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  • K090153 — SPI VARIOMULTI ANGLED ABUTMENT (March 27, 2009)

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