Not currently registered with FDA under this name
Imtec Corp.
Ardmore, OK, United States. Named as applicant on 24 dental 510(k) clearances between 1991 and 2008. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 241991–2008
- Markets registered in
- 315 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Imtec Corp. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Imtec Corp. | 24 clearances | 1991–2008 | Below |
| South Korea | MFDS | Manufacturer | IMTEC CorporationIMTEC CORPORATION · IMTEC Corp. · +1 | 14 | 1999–2008 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | IMTEC CORPORATION | 1 | 2006–2006 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Imtec Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Sep 2008 | K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM | DZE Root-Form Endosseous Implant |
| 12 Dec 2007 | K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 | DZE Root-Form Endosseous Implant |
| 13 Jan 2005 | K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 | DZE Root-Form Endosseous Implant |
| 15 Sep 2004 | K042289 | MDI ORTHO | DZE Root-Form Endosseous Implant |
| 15 Jan 2004 | K033432 | LEXATITE QUICK ACRYLIC | EBG Resin Temporary Crown and Bridge |
| 12 Aug 2003 | K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX | DZE Root-Form Endosseous Implant |
| 23 Apr 2003 | K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | DZE Root-Form Endosseous Implant |
| 21 Feb 2003 | K024044 | SABER TECH IMPLANTS SYSTEM | DZE Root-Form Endosseous Implant |
| 3 Dec 2002 | K023067 | IMTEC SENDAX MDI ORTHO6 AND ORTHO8 | DZE Root-Form Endosseous Implant |
| 19 Jul 2002 | K021437 | SECURE SOFT | EBI Rebasing Repairing Relining Denture Resin |
| 14 Jun 2002 | K021586 | SECURE RELINE/PICKUP MATERIAL | EBI Rebasing Repairing Relining Denture Resin |
| 10 Apr 2002 | K020396 | BIOCELLECT -PERIO | LYC Synthetic Bone Grafting Material |
| 12 Jun 2001 | K010775 | BIOCELLECT | LYC Synthetic Bone Grafting Material |
| 21 Jun 1999 | K982951 | IMTEC BIOPIN | DZL Intraosseous Fixation Screw |
| 13 Apr 1999 | K990983 | MODIFICATION TO IMTEC SENDAX MDI | DZE Root-Form Endosseous Implant |
| 3 Mar 1998 | K974752 | IMTEC/BIOBARRIER MEMBRANE | NPK Intraoral Synthetic Barrier |
| 19 Nov 1997 | K973248 | IMTEC BONE COLLECTOR SYSTEM | EHZ Oral Cavity Evacuator |
| 18 Nov 1997 | K973180 | IMTEC BONE TAC | DZL Intraosseous Fixation Screw |
| 26 Aug 1997 | K972240 | IMTEC BIOBARRIER MEMBRANE | NPK Intraoral Synthetic Barrier |
| 30 Apr 1997 | K970841 | IMTEC/TITANIUM MESH | JEY Bone Plate |
| 6 Feb 1996 | K950306 | IMTEC BIOBARRIER | LYC Synthetic Bone Grafting Material |
| 24 Aug 1994 | K932168 | HEXLOCK/HEXLOCK SCREW | DZE Root-Form Endosseous Implant |
| 12 Jan 1993 | K920909 | HEXLOCK SCREW | DZE Root-Form Endosseous Implant |
| 10 Dec 1991 | K912262 | HEXLOCK | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Solventum US LLC (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.