Company ยท US
Imtec Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2008. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 12 |
| LYC | Bone Grafting Material, Synthetic | 3 |
| DZL | Screw, Fixation, Intraosseous | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 |
| NPK | Barrier, Synthetic, Intraoral | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EHZ | Evacuator, Oral Cavity | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 |
| JEY | Plate, Bone | 1 |
| KKO | Ring, Teething, Fluid-Filled | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 19, 2008 | K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM Imtec Corp. | DZE |
| May 28, 2008 | K081347 | ILUMA VISION Imtec Corp. | LLZ |
| Dec 12, 2007 | K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 Imtec Corp. | DZE |
| Nov 8, 2005 | K053046 | ILUMA ORTHOCAT/DENTALCAT Imtec Corp. | JAK |
| Jan 13, 2005 | K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 Imtec Corp. | DZE |
| Sep 15, 2004 | K042289 | MDI ORTHO Imtec Corp. | DZE |
| Jan 15, 2004 | K033432 | LEXATITE QUICK ACRYLIC Imtec Corp. | EBG |
| Aug 12, 2003 | K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX Imtec Corp. | DZE |
| Apr 23, 2003 | K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 Imtec Corp. | DZE |
| Feb 21, 2003 | K024044 | SABER TECH IMPLANTS SYSTEM Imtec Corp. | DZE |
| Dec 3, 2002 | K023067 | IMTEC SENDAX MDI ORTHO6 AND ORTHO8 Imtec Corp. | DZE |
| Jul 19, 2002 | K021437 | SECURE SOFT Imtec Corp. | EBI |
| Jun 14, 2002 | K021586 | SECURE RELINE/PICKUP MATERIAL Imtec Corp. | EBI |
| Apr 10, 2002 | K020396 | BIOCELLECT -PERIO Imtec Corp. | LYC |
| Jun 12, 2001 | K010775 | BIOCELLECT Imtec Corp. | LYC |
| Jun 21, 1999 | K982951 | IMTEC BIOPIN Imtec Corp. | DZL |
| Apr 13, 1999 | K990983 | MODIFICATION TO IMTEC SENDAX MDI Imtec Corp. | DZE |
| Mar 3, 1998 | K974752 | IMTEC/BIOBARRIER MEMBRANE Imtec Corp. | NPK |
| Nov 19, 1997 | K973248 | IMTEC BONE COLLECTOR SYSTEM Imtec Corp. | EHZ |
| Nov 18, 1997 | K973180 | IMTEC BONE TAC Imtec Corp. | DZL |
| Aug 26, 1997 | K972240 | IMTEC BIOBARRIER MEMBRANE Imtec Corp. | NPK |
| Apr 30, 1997 | K970841 | IMTEC/TITANIUM MESH Imtec Corp. | JEY |
| Feb 6, 1996 | K950306 | IMTEC BIOBARRIER Imtec Corp. | LYC |
| Aug 24, 1994 | K932168 | HEXLOCK/HEXLOCK SCREW Imtec Corp. | DZE |
| Jun 9, 1994 | K923260 | LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED Imtec Corp. | HET |
| Apr 11, 1994 | K923259 | LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS Imtec Corp. | HET |
| Jan 12, 1993 | K920909 | HEXLOCK SCREW Imtec Corp. | DZE |
| Dec 10, 1991 | K912262 | HEXLOCK Imtec Corp. | DZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2009 | IMTEC Corporation MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant.
The product is used as a endosseous dental implant. Terminated |
KKO | K081653 |