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510(k) K053046

ILUMA ORTHOCAT/DENTALCAT by Imtec Corp. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2005
Date Received
October 28, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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  • 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)
  • K030243 — ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 (April 23, 2003)
  • K024044 — SABER TECH IMPLANTS SYSTEM (February 21, 2003)
  • K023067 — IMTEC SENDAX MDI ORTHO6 AND ORTHO8 (December 3, 2002)

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