Artech Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Artech Corp.” (first 1984, latest 1992), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 106 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 | 6 | 6 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 2 | 2 |
Review panels
- Dental (8)
Most recent Artech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911735 | ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT | DZE | 1992-03-05 | 323 |
| K895267 | ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT | DZE | 1990-04-10 | 230 |
| K891346 | ARTECH TYPE SS SUBMERGED SCREW IMPLANT | DZE | 1989-12-21 | 286 |
| K894160 | HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL | DZE | 1989-09-28 | 106 |
| K894151 | IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT | DZJ | 1989-09-27 | 105 |
| K894150 | COUNTERBORE FOR SS SUBMERGED SCREW PLANT | DZJ | 1989-09-27 | 105 |
| K843217 | HOLLOW BASKET DENTAL IMPLANTS | DZE | 1984-10-15 | 61 |
| K843218 | TPS SCREW DENTAL IMPLANTS | DZE | 1984-09-27 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Artech Corp..
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 Artech Corp.?
FDA lists 8 510(k) clearances under the applicant name “Artech Corp.” (first 1984, latest 1992), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Artech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Artech Corp. is 106 days.
Which FDA product codes appear under Artech Corp.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6); DZJ (Driver, Wire, And Bone Drill, Manual, 2).
Next steps
- See all 8 Artech Corp. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Artech 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.