Manufacturer registered with FDA
Osstell AB
GOTEBORG, Sweden. Lists 1 dental device type with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 28
- 510(k) clearances
- 52008–2026
- Markets registered in
- 1454 registrations outside the US
- Establishments
- 1Sweden
510(k) clearances per year, 2000–2026
Registered in 14 markets
Where regulators' registries name Osstell 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 | Osstell AB | 5 clearances | 2008–2026 | Below |
| Canada | Health Canada | Registration holder | OSSTELL AB | 12 | 2008–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Osstell AB | 8 | 2018–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Osstell AB | 7 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OSSTELL ABOsstell AB | 7 | 2008–2018 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Osstell AB | 4 | 2024–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Osstell AB | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Osstell AB | 3 | 2004–2016 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | OSSTELL AB | 2 | 2021–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | Osstell AB | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Osstell AB | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Osstell AB | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 欧斯泰（医疗）有限责任公司Osstell AB | 1 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | OSSTELL AB | 1 | — | 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 Osstell 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 |
|---|---|---|---|---|
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Mega ISQ IINeoTellOsstell BeaconOsstell ClassicSmart Pegs Type 1-111SmartPeg Type 004RSmartPeg Type 005RSmartPeg Type 006RSmartPeg Type 007RSmartPeg Type 01 - 123, 127, 137, A3 18 moreSmartPeg Type 011RSmartPeg Type 015RSmartPeg Type 023RSmartPeg Type 025RSmartPeg Type 026RSmartPeg Type 027RSmartPeg Type 032RSmartPeg Type 038RSmartPeg Type 053RSmartPeg Type 054RSmartPeg Type 060RSmartPeg Type 061RSmartPeg Type 095RSmartPeg Type 116RSmartPeg Type 117, 127, 137SmartPeg Type 119RSmartPeg Type 121RSmartPeg Type 122R | 2014 |
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 Osstell AB as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Sep 2026 | K261987 | Reusable SmartPeg | EKX Ac-Powered Direct Drive Handpiece |
| 22 Aug 2019 | K181888 | Osstell Beacon | EKX Ac-Powered Direct Drive Handpiece |
| 19 Feb 2015 | K142358 | Osstell IDx | EKX Ac-Powered Direct Drive Handpiece |
| 9 Apr 2014 | K132401 | MEGA ISQ | EKX Ac-Powered Direct Drive Handpiece |
| 26 Sep 2008 | K082523 | OSSTELL ISQ IMPLANT STABILITY METER | EKX Ac-Powered Direct Drive Handpiece |
Some of these clearances are listed with FDA today by another company: Neoss AB (1), Nobel Biocare Services AG (1), W.H. Holden Inc. DBA H & H Company (1), DIO Corporation (1), W&H Dentalwerk Buermoos GmbH (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OSSTELL ABFDA reg. 3004070020 | GOTEBORG Vastra Gotaland, Sweden | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9059818). 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.