Imtec Corp.
Medical device manufacturer in Ardmore, OK.
28510(k) clearances
0PMA approvals
1recalls
Device types
- DZE Implant, Endosseous, Root-Form 12
- LYC Bone Grafting Material, Synthetic 3
- HET Laparoscope, Gynecologic (And Accessories) 2
- NPK Barrier, Synthetic, Intraoral 2
- DZL Screw, Fixation, Intraosseous 2
- EBI Resin, Denture, Relining, Repairing, Rebasing 2
- JEY Plate, Bone 1
- EHZ Evacuator, Oral Cavity 1
- EBG Crown And Bridge, Temporary, Resin 1
- JAK System, X-Ray, Tomography, Computed 1
- LLZ System, Image Processing, Radiological 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K081653 | Mdi Mii One-Piece Implant, 2.9MMDZE · Traditional | 09/19/2008SE |
| K081347 | Iluma VisionLLZ · Traditional | 05/28/2008SE |
| K072660 | Endure Implant, Model 5108, 5111, 5113, 5114DZE · Traditional | 12/12/2007SE |
| K053046 | Iluma Orthocat/DentalcatJAK · Abbreviated | 11/08/2005SE |
| K043226 | Endure Implant, Models 3508, 4308, 3520, 4320DZE · Traditional | 01/13/2005SE |
| K042289 | Mdi OrthoDZE · Traditional | 09/15/2004SE |
| K033432 | Lexatite Quick AcrylicEBG · Traditional | 01/15/2004SE |
| K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, MOB-22, Msh-XxDZE · Traditional | 08/12/2003SE |
| K030243 | Endure Implant, Model 3508,3511,3514,4308,4311,4314DZE · Traditional | 04/23/2003SE |
| K024044 | Saber Tech Implants SystemDZE · Traditional | 02/21/2003SE |
| K023067 | Imtec Sendax Mdi ORTHO6 and ORTHO8DZE · Traditional | 12/03/2002SE |
| K021437 | Secure SoftEBI · Traditional | 07/19/2002SE |
| K021586 | Secure Reline/Pickup MaterialEBI · Traditional | 06/14/2002SE |
| K020396 | Biocellect -PerioLYC · Traditional | 04/10/2002SE |
| K010775 | BiocellectLYC · Traditional | 06/12/2001SE |
| K982951 | Imtec BiopinDZL · Traditional | 06/21/1999SE |
| K990983 | Modification to Imtec Sendax MdiDZE · Special | 04/13/1999SE |
| K974752 | Imtec/Biobarrier MembraneNPK · Traditional | 03/03/1998SE |
| K973248 | Imtec Bone Collector SystemEHZ · Traditional | 11/19/1997SE |
| K973180 | Imtec Bone TacDZL · Traditional | 11/18/1997SE |
| K972240 | Imtec Biobarrier MembraneNPK · Traditional | 08/26/1997SE |
| K970841 | Imtec/Titanium MeshJEY · Traditional | 04/30/1997SE |
| K950306 | Imtec BiobarrierLYC · Traditional | 02/06/1996SE |
| K932168 | Hexlock/Hexlock ScrewDZE · Traditional | 08/24/1994SE |
| K923260 | Laparoscopy Sets, Needle Holders, Blunt CurvedHET · Traditional | 06/09/1994SE |
| K923259 | Laparoscopy Sets, Needle Holders, Blunt ShearsHET · Traditional | 04/11/1994SE |
| K920909 | Hexlock ScrewDZE · Traditional | 01/12/1993SE |
| K912262 | HexlockDZE · Traditional | 12/10/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1997-2009 | MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous…Size printed on product packaging does not match size of enclosed product. | 07/07/2009Terminated |