510(k) Report

FDA applicant

Imtec Corp.

Ardmore, OK28 decisions1991–20083 recalls

FDA records 28 decisions for Imtec Corp. (Ardmore, OK) from 1991 to 2008: 28 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and LYC (Bone Grafting Material, Synthetic). Its devices cite 16 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Imtec Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007: 12008: 2
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2010

2009: 22010: 1
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Imtec Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Imtec Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form12decisions
  • LYCBone Grafting Material, Synthetic3decisions
  • NPKBarrier, Synthetic, Intraoral2decisions
  • DZLScrew, Fixation, Intraosseous2decisions
  • HETLaparoscope, Gynecologic (And Accessories)2decisions
  • EBIResin, Denture, Relining, Repairing, Rebasing2decisions

Also: LLZ (1), EBG (1), JAK (1), EHZ (1), JEY (1).

Whose devices does it build on?

Its devices cite 16 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 55 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K031106Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXImtec Corp. · 200323cite it
  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 20088cite it
  • K023067Imtec Sendax Mdi ORTHO6 and ORTHO8Imtec Corp. · 20025cite it
  • K973180Imtec Bone TacImtec Corp. · 19974cite it
  • K042289Mdi OrthoImtec Corp. · 20043cite it
  • K990983Modification to Imtec Sendax MdiImtec Corp. · 19993cite it

What has FDA decided for it lately?

  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 20081 recall
  • K081347Iluma VisionImtec Corp. · 20081 recall
  • K072660Endure Implant, Model 5108, 5111, 5113, 5114Imtec Corp. · 2007
  • K053046Iluma Orthocat/DentalcatImtec Corp. · 2005
  • K043226Endure Implant, Models 3508, 4308, 3520, 4320Imtec Corp. · 2005
  • K042289Mdi OrthoImtec Corp. · 2004
  • K033432Lexatite Quick AcrylicImtec Corp. · 2004
  • K031106Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXImtec Corp. · 20031 recall

All 28 as Imtec Corp. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K031106S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic HeadMay 14, 2010
  • K081347ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product…Aug 3, 2009
  • K081653MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous…Jul 7, 2009