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510(k) K073142

NOBELREPLACE HEXAGONAL IMPLANT by Nobel Biocare USA, LLC — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2008
Date Received
November 7, 2007
Clearance Type
Special
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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  • K050641 — ZYGOMA TIUNITE (April 7, 2005)
  • K043312 — NOBELRONDO DENTAL CERAMIC - ZIRCONIA (February 1, 2005)

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