Imtec Corp.
Ardmore, OK, US
Imtec Corp. appears in FDA device records in Ardmore, OK. FDA records list 26 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Imtec Corp. between 1991 and 2008. The busiest year on record is 1997, with 4. The most recent is 2008, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 4 |
| 1998 | 1 |
| 1999 | 2 |
| 2001 | 1 |
| 2002 | 4 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM | DZE | Substantially Equivalent | |
| K081347 | ILUMA VISION | LLZ | Substantially Equivalent | |
| K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 | DZE | Substantially Equivalent | |
| K053046 | ILUMA ORTHOCAT/DENTALCAT | JAK | Substantially Equivalent | |
| K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 | DZE | Substantially Equivalent | |
| K042289 | MDI ORTHO | DZE | Substantially Equivalent | |
| K033432 | LEXATITE QUICK ACRYLIC | EBG | Substantially Equivalent | |
| K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX | DZE | Substantially Equivalent | |
| K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | DZE | Substantially Equivalent | |
| K024044 | SABER TECH IMPLANTS SYSTEM | DZE | Substantially Equivalent | |
| K023067 | IMTEC SENDAX MDI ORTHO6 AND ORTHO8 | DZE | Substantially Equivalent | |
| K021437 | SECURE SOFT | EBI | Substantially Equivalent | |
| K021586 | SECURE RELINE/PICKUP MATERIAL | EBI | Substantially Equivalent | |
| K020396 | BIOCELLECT -PERIO | LYC | Substantially Equivalent | |
| K010775 | BIOCELLECT | LYC | Substantially Equivalent | |
| K982951 | IMTEC BIOPIN | DZL | Substantially Equivalent | |
| K990983 | MODIFICATION TO IMTEC SENDAX MDI | DZE | Substantially Equivalent | |
| K974752 | IMTEC/BIOBARRIER MEMBRANE | NPK | Substantially Equivalent | |
| K973248 | IMTEC BONE COLLECTOR SYSTEM | EHZ | Substantially Equivalent | |
| K973180 | IMTEC BONE TAC | DZL | Substantially Equivalent | |
| K972240 | IMTEC BIOBARRIER MEMBRANE | NPK | Substantially Equivalent | |
| K970841 | IMTEC/TITANIUM MESH | JEY | Substantially Equivalent | |
| K950306 | IMTEC BIOBARRIER | LYC | Substantially Equivalent | |
| K932168 | HEXLOCK/HEXLOCK SCREW | DZE | Substantially Equivalent | |
| K920909 | HEXLOCK SCREW | DZE | Substantially Equivalent | |
| K912262 | HEXLOCK | DZE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- NPKBarrier, Synthetic, Intraoral
- LYCBone Grafting Material, Synthetic
- EBGCrown And Bridge, Temporary, Resin
- EHZEvacuator, Oral Cavity
- DZEImplant, Endosseous, Root-Form
- JEYPlate, Bone
- EBIResin, Denture, Relining, Repairing, Rebasing
- DZLScrew, Fixation, Intraosseous
- LLZSystem, Image Processing, Radiological
- JAKSystem, X-Ray, Tomography, Computed
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain