Data / Medical devices / Israel / Forum Engineering Technologies (96) Ltd.
Forum Engineering Technologies (96) Ltd.: FDA-registered device maker in Ashkelon Southern, Israel, 4 510(k) clearances
Forum Engineering Technologies (96) Ltd. is registered with the FDA (registration 3005164841) in Ashkelon Southern, Israel. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 9, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005164841
- Address
- 40 Hutsot HaYotser St. South Industrial Zone, Ashkelon Southern, Israel, 7878563
- Owner or operator
- Forum Engineering Technologies (96) Ltd. (10038791)
- Roles
- Manufacturer
- First device listed
- November 13, 2011
- Registered through
- 2026
- Brand names listed
- BINGO PRO, CanalPro, Detect, EM-07 Cordless Endo Motor, Endo-Eze® Find, Apex Locator, NovApex N31, Propex-Pixi® Apex Locator, Raypex 7 Apex Locator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | 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 |
|---|---|---|---|---|---|---|
| July 9, 2024 | K232551 | EM-07 Cordless Endo Motor | EKX | Substantially Equivalent | Forum Engineering Technologies (96) , Ltd. | accessdata.fda.gov |
| January 10, 2013 | K121206 | DETECT | LQY | Substantially Equivalent | Forum Engineering Technologies, Ltd. | accessdata.fda.gov |
| November 2, 2011 | K111474 | BINGO PRO | LQY | Substantially Equivalent | Forum Engineering Technologies (96) , Ltd. | accessdata.fda.gov |
| September 3, 2010 | K101054 | ROMIAPEX MODEL A-15 | LQY | Substantially Equivalent | Romidan, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Locator, Root Apex
- All makers of Handpiece, Direct Drive, Ac-Powered
Updated July 9, 2024. 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.