Data / Medical devices / United States / Zentek Medical LLC
Zentek Medical LLC: FDA-registered device maker in Manalapan, NJ, United States, 6 510(k) clearances
Zentek Medical LLC is registered with the FDA (registration 3017125693) in Manalapan, NJ, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017125693
- Address
- 81 Pension Road Suite 116, Manalapan, NJ, United States, 07726
- Owner or operator
- Zentek Medical LLC (10076447)
- Roles
- Specification developer
- First device listed
- July 20, 2020
- Registered through
- 2026
- Brand names listed
- Bonafix, Bonafix 2 Plus, Bonafix Ti Base, Dentlot, Duranext Duo, Implant replica Zenanrh, Orthodontic screw, Zentek and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | 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 |
|---|---|---|---|---|---|---|
| October 15, 2025 | K251294 | Bonafix Implant Abutments | NHA | Substantially Equivalent | Zentek Medical, LLC | accessdata.fda.gov |
| July 14, 2023 | K221673 | Bonafix TiBase | NHA | Substantially Equivalent | Zentek Medical, LLC | accessdata.fda.gov |
| December 20, 2022 | K213677 | Bonafix 2 Plus | DZE | Substantially Equivalent | Zentek Medical, LLC | accessdata.fda.gov |
| July 14, 2017 | K162853 | Bonafix TWO - Dental Implant System | DZE | Substantially Equivalent | Bonafix Surgical and Dental Implants | accessdata.fda.gov |
| November 28, 2012 | K122052 | MINIFIX BALL MINIFIX ONE | DZE | Substantially Equivalent | Bonafix Surgical and Dental Implants, LLC | accessdata.fda.gov |
| October 3, 2012 | K113650 | ORTHOFIX SCREW | OAT | Substantially Equivalent | Bonafix Surgical and Dental Implants, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Orthodontic
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
Updated October 15, 2025. 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.