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510(k) K030243

ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 by Imtec Corp. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2003
Date Received
January 23, 2003
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

Other clearances by Imtec Corp.

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  • K053046 — ILUMA ORTHOCAT/DENTALCAT (November 8, 2005)
  • K043226 — ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 (January 13, 2005)
  • K042289 — MDI ORTHO (September 15, 2004)
  • K033432 — LEXATITE QUICK ACRYLIC (January 15, 2004)
  • K031106 — IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, M (August 12, 2003)
  • K024044 — SABER TECH IMPLANTS SYSTEM (February 21, 2003)
  • K023067 — IMTEC SENDAX MDI ORTHO6 AND ORTHO8 (December 3, 2002)

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