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510(k) K994376

FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA by Friadent GmbH — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2000
Date Received
December 27, 1999
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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  • K024004 — XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM (March 3, 2003)
  • K023799 — FRIOS ALGIPORE (February 5, 2003)
  • K021318 — XIVE DENTAL IMPLANT SYSTEM (July 2, 2002)

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