Manufacturer registered with FDA
Dentatus AB
SPANGA, Sweden. Lists 16 dental device types with FDA across 1 registered establishment.
- Device types listed
- 16
- Brands and models
- 51
- 510(k) clearances
- 0as applicant
- Markets registered in
- 655 registrations outside the US
- Establishments
- 1Sweden
Registered in 6 markets
Where regulators' registries name Dentatus AB as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dentatus AB | 16 device types | — | Below |
| Canada | Health Canada | Registration holder | DENTATUS AB | 34 | 2006–2015 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Dentatus AB | 10 | 2004–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTATUS AB | 6 | 2005–2019 | Pure Global AI |
| Israel | AMAR | Manufacturer | Dentatus AB | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Dentatus AB | 1 | 2015–2015 | 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 AB 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 | Maker | RSARSBRSCRSGRSHRSIRUARUBRUDRUF 2 moreRUGRUH | 2004 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | ANEWAtlasMTI Monorail | 2008 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dentatus Matrix BandsForms-to-Fit | 1988 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Dentatus Diamond InstrumentsFD | 1981 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | TufLink | 2008 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | Luminex | 2004 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Profin/EVAProfinet | 2009 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | EVA TipsLTA Lamineer TipsPer-io-Tor Tips | 2004 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | DENTATUS | 1998 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Profin-By-Hand | 2004 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | CePo Pilot drills | 2009 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | ARDARHARLARL/PMaaxloc | 1981 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | AztecClassicLuscentLuscent-RSterile SurtexSurtex ClassicTwin Luscent | 1981 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | MEC | 1981 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | AEB FacebowAEC FacebowAEE FacebowAEK FacebowAEP FacebowAEV Facebow | 1981 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Anew acessoriesAtlas acessoriesMTI Monorail acessories | 2004 |
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
Dentatus AB 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: Dentatus USA Ltd. (1), Nats Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Dec 2004 | K042931 | TUF LINK SILICONE RELINER | Dentatus USA Ltd. | EBI Rebasing Repairing Relining Denture Resin |
| 13 Sep 2004 | K040143 | MONORAIL | Nats Corp. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTATUS ABFDA reg. 8030870 | SPANGA Stockholm, Sweden | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030870). 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.