Manufacturer registered with FDA
Biotech Dental
Englewood, NJ, United States. Lists 6 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 6
- Brands and models
- 10
- 510(k) clearances
- 12024–2024
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Biotech Dental currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | KontactReflect | 2021 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | KontactReflect | 2021 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | Y-Brush | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | KontactReflect | 2021 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Lister | Smilers | 2022 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Lister | Implant Prosthetic KitImplant Surgical Kit | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Biotech Dental 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: Biotech Dental (2), Biotech Dental Smilers, SAS (1), Ids - Integrated Dental Systems (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Jul 2022 | K213997 | Kontact Dental Implant System | Biotech Dental | DZE Root-Form Endosseous Implant |
| 20 Sep 2021 | K212961 | SMILERS | Biotech Dental Smilers, SAS | NXC Sequential Aligner |
| 18 Jun 2021 | K210220 | Kontact Dental Implant System | Biotech Dental | DZE Root-Form Endosseous Implant |
| 29 Mar 2019 | K180924 | Reflect Implant System | Ids - Integrated Dental Systems | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Biotech DentalFDA reg. 3010730876 | Englewood, NJ, United States | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083785). 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.