Manufacturer registered with FDA
Zentek Medical LLC
Manalapan, NJ, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 13
- 510(k) clearances
- 32022–2025
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Zentek Medical LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | BonafixBonafix 2 PlusBonafix Ti BaseDentlotDuranext DuoZentek | 2020 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Bonafix 2 PlusDentlotDuranext DuoZentekZentek smart | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Implant replica Zenanrh | 2020 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | Orthodontic screw | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Zentek Medical LLC as the applicant.
Also lists devices cleared under other names
Zentek Medical LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Bonafix Surgical and Dental Implants (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Jul 2017 | K162853 | Bonafix TWO - Dental Implant System | Bonafix Surgical and Dental Implants | DZE Root-Form Endosseous Implant |
| 28 Nov 2012 | K122052 | MINIFIX BALL MINIFIX ONE | Bonafix Surgical and Dental Implants | DZE Root-Form Endosseous Implant |
| 3 Oct 2012 | K113650 | ORTHOFIX SCREW | Bonafix Surgical and Dental Implants | OAT Orthodontic Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ZENTEK MEDICAL LLCFDA reg. 3017125693 | Manalapan, NJ, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10076447). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.