Imtec Corp.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Imtec Corp.” (first 1991, latest 2008), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 12 | 12 |
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
| DZL | Screw, Fixation, Intraosseous | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| NPK | Barrier, Synthetic, Intraoral | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EHZ | Evacuator, Oral Cavity | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (24)
- Obstetrics and Gynecology (2)
- Radiology (2)
Most recent Imtec Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM | DZE | 2008-09-19 | 99 |
| K081347 | ILUMA VISION | LLZ | 2008-05-28 | 14 |
| K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 | DZE | 2007-12-12 | 82 |
| K053046 | ILUMA ORTHOCAT/DENTALCAT | JAK | 2005-11-08 | 11 |
| K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 | DZE | 2005-01-13 | 52 |
| K042289 | MDI ORTHO | DZE | 2004-09-15 | 22 |
| K033432 | LEXATITE QUICK ACRYLIC | EBG | 2004-01-15 | 79 |
| K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX | DZE | 2003-08-12 | 126 |
| K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | DZE | 2003-04-23 | 90 |
| K024044 | SABER TECH IMPLANTS SYSTEM | DZE | 2003-02-21 | 77 |
18 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-07-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Imtec Corp.?
FDA lists 28 510(k) clearances under the applicant name “Imtec Corp.” (first 1991, latest 2008), across 11 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Imtec Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imtec Corp. is 80 days.
Which FDA product codes appear under Imtec Corp.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 12); LYC (Bone Grafting Material, Synthetic, 3); DZL (Screw, Fixation, Intraosseous, 2).
Next steps
- See all 28 Imtec Corp. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Imtec Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.