Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imtec Corp. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
476 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM | Imtec Corp. | 2008-09-19 | 99 | 1 |
| K081347 | ILUMA VISION | Imtec Corp. | 2008-05-28 | 14 | 1 |
| K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 | Imtec Corp. | 2007-12-12 | 82 | 0 |
| K053046 | ILUMA ORTHOCAT/DENTALCAT | Imtec Corp. | 2005-11-08 | 11 | 0 |
| K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 | Imtec Corp. | 2005-01-13 | 52 | 0 |
| K042289 | MDI ORTHO | Imtec Corp. | 2004-09-15 | 22 | 0 |
| K033432 | LEXATITE QUICK ACRYLIC | Imtec Corp. | 2004-01-15 | 79 | 0 |
| K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB- | Imtec Corp. | 2003-08-12 | 126 | 1 |
| K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | Imtec Corp. | 2003-04-23 | 90 | 0 |
| K024044 | SABER TECH IMPLANTS SYSTEM | Imtec Corp. | 2003-02-21 | 77 | 0 |
| K023067 | IMTEC SENDAX MDI ORTHO6 AND ORTHO8 | Imtec Corp. | 2002-12-03 | 78 | 0 |
| K021437 | SECURE SOFT | Imtec Corp. | 2002-07-19 | 74 | 0 |
| K021586 | SECURE RELINE/PICKUP MATERIAL | Imtec Corp. | 2002-06-14 | 31 | 0 |
| K020396 | BIOCELLECT -PERIO | Imtec Corp. | 2002-04-10 | 63 | 0 |
| K010775 | BIOCELLECT | Imtec Corp. | 2001-06-12 | 90 | 0 |
| K982951 | IMTEC BIOPIN | Imtec Corp. | 1999-06-21 | 301 | 0 |
| K990983 | MODIFICATION TO IMTEC SENDAX MDI | Imtec Corp. | 1999-04-13 | 20 | 0 |
| K974752 | IMTEC/BIOBARRIER MEMBRANE | Imtec Corp. | 1998-03-03 | 74 | 0 |
| K973248 | IMTEC BONE COLLECTOR SYSTEM | Imtec Corp. | 1997-11-19 | 82 | 0 |
| K973180 | IMTEC BONE TAC | Imtec Corp. | 1997-11-18 | 85 | 0 |
| K972240 | IMTEC BIOBARRIER MEMBRANE | Imtec Corp. | 1997-08-26 | 71 | 0 |
| K970841 | IMTEC/TITANIUM MESH | Imtec Corp. | 1997-04-30 | 54 | 0 |
| K950306 | IMTEC BIOBARRIER | Imtec Corp. | 1996-02-06 | 377 | 0 |
| K932168 | HEXLOCK/HEXLOCK SCREW | Imtec Corp. | 1994-08-24 | 476 | 0 |
| K923260 | LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED | Imtec Corp. | 1994-06-09 | 707 | 0 |
| K923259 | LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS | Imtec Corp. | 1994-04-11 | 648 | 0 |
| K920909 | HEXLOCK SCREW | Imtec Corp. | 1993-01-12 | 320 | 0 |
| K912262 | HEXLOCK | Imtec Corp. | 1991-12-10 | 202 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda