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510(k) K080162

UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT by Mis Implants Technologies , Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2008
Date Received
January 23, 2008
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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  • K092555 — UNO NARROW IMPLANT (January 5, 2010)
  • K073461 — ORTHO ANCHOR SCREWS (January 25, 2008)

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