Data / Medical devices / Israel / Abracadabra Implants Ltd.
Abracadabra Implants Ltd.: FDA-registered device maker in Or Yehuda Central, Israel, 1 510(k) clearance
Abracadabra Implants Ltd. is registered with the FDA (registration 3021076825) in Or Yehuda Central, Israel. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021076825
- Address
- Haharoshet 12, Or Yehuda Central, Israel, 6037580
- Owner or operator
- Abracadabra Implants Ltd. (10083470)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 23, 2021
- Registered through
- 2026
- Brand names listed
- AM40-Analog 4 mm Metalic, AP40-Analog 4 mm Plastic, BO0833 - Bolero 3.3 mm in diameter, BO0837 - Bolero 3.75 mm in diameter, BO0842 - Bolero 4.2 mm in diameter, BO0850 - Bolero 5 mm in diameter, BO0860 - Bolero 6 mm in diameter, BO1033 - Bolero 3.3 mm in diameter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Punch, Biopsy, Surgical | EME | 1 | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 23, 2021 | K202092 | ABC Dental Implant System | DZE | Substantially Equivalent | Abracadabra Implants , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Punch, Biopsy, Surgical
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Pin, Retentive And Splinting, And Accessory Instruments
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Bur, Dental
Updated September 23, 2021. 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.