Data / Medical devices / Israel / Hi Tec Implants, Ltd.
Hi Tec Implants, Ltd.: FDA-registered device maker in HERZLIA Tel Aviv, Israel, 1 510(k) clearance
Hi Tec Implants, Ltd. is registered with the FDA (registration 9613283) in HERZLIA Tel Aviv, Israel. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 17, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613283
- FEI number
- 3004471724
- Address
- 20 Galgalei Plada ST., HERZLIA Tel Aviv, Israel, 46722
- Owner or operator
- HI TEC IMPLANTS, LTD. (9010116)
- Roles
- Manufacturer
- First device listed
- April 5, 2006
- Registered through
- 2026
- Brand names listed
- AAT, AAT-L, ACA, ACA-0, ACA-E, ACA-G, ACA-P, ACA-R and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 17, 1994 | K941575 | SMOOTH FIT | DZE | Substantially Equivalent | Hi-Tec Implants | accessdata.fda.gov |
Compare with other makers
- All makers of Bur, Dental
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
Updated November 17, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.