Registered with FDA
Dentatus USA Ltd.
Hawthorne, NY, United States. Lists 11 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 15
- 510(k) clearances
- 41996–2004
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Dentatus USA Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Dentatus USA Ltd. | 4 clearances | 1996–2004 | Below |
| Canada | Health Canada | Registration holder | DENTATUS USA LTD. | 1 | 2010–2010 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Dentatus USA Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Classic Reamer | 2011 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | ParmaxProfin | 2011 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | EVA | 2011 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Lister | Parallel-A-Prep | 2011 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | LTA/EVA tips | 2011 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | Profin | 2011 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | Articulators | 2011 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | LuminexParmax | 2011 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | Parallel-A-Prep | 2011 |
| FacebowKCR · Class 1 | Articulators & facebows | Lister | Facebow | 2011 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | AnewAtlas,MTI | 2011 |
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 Dentatus USA Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Dec 2004 | K042931 | TUF LINK SILICONE RELINER | EBI Rebasing Repairing Relining Denture Resin |
| 13 Nov 2003 | K031793 | DENTATUS OSCIOMAT | DZH Ac-Powered Bone Saw |
| 15 May 1998 | K980620 | DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM | DZE Root-Form Endosseous Implant |
| 26 Jul 1996 | K961704 | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM | ELS Endodontic Stabilizing Splint |
Some of these clearances are listed with FDA today by another company: Dentatus AB (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTATUS USA LTD.FDA reg. 2435118 | Hawthorne, NY, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10026895). 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.