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510(k) K053046

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

K053046 is an FDA 510(k) premarket notification submitted by Imtec Corp. for the device "ILUMA ORTHOCAT/DENTALCAT". The FDA issued a decision of Substantially Equivalent on November 8, 2005. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Imtec Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by Imtec Corp.

  • K081653 — MDI MII ONE-PIECE IMPLANT, 2.9MM (September 19, 2008)
  • K081347 — ILUMA VISION (May 28, 2008)
  • K072660 — ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 (December 12, 2007)
  • 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)
  • 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)

Other clearances for product code JAK

  • K253560 — Enhanced Boundary for PCCT (June 24, 2026)
  • K253026 — Respiratory Gating for Scanners (2.1) (June 4, 2026)
  • K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0 (May 20, 2026)
  • K253649 — Spectral CT Verida Family (March 27, 2026)
  • K252992 — CT Rembra RT; CT Areta RT; CT Rembra (March 23, 2026)
  • K253686 — True Definition DL (March 23, 2026)
  • K253520 — Photonova Spectra, Photonova Spectra Select (March 20, 2026)
  • K253574 — SOMATOM X.cite; SOMATOM X.ceed (March 20, 2026)
  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)

FDA data resources