Manufacturer registered with FDA
Integration Diagnostics Sweden AB
Goteborg, Sweden. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 929 registrations outside the US
- Establishments
- 1Sweden
Registered in 9 markets
Where regulators' registries name Integration Diagnostics Sweden 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 | Integration Diagnostics Sweden AB | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | Integration Diagnostics Sweden ABINTEGRATION DIAGNOSTICS SWEDEN AB | 9 | 2017–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Integration Diagnostics Sweden AB | 7 | 2015–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Integration Diagnostics Sweden AB | 5 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Integration Diagnostics Sweden AB. | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | INTEGRATION DIAGNOSTICS SWEDEN AB | 2 | 2023–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | INTEGRATION DIAGNOSTICS SWEDEN AB. | 1 | 2026–2026 | Pure Global AI |
| China | NMPA | Registration holder | 瑞典集成诊断公司Integration Diagnostics Sweden AB | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Integration Diagnostics Sweden 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 Integration Diagnostics Sweden 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 | IS3IS4Locking screwdriverMDI MulTipegMulTipegMulTipeg DriverOsseo 100Osseo 100+Penguin IIPenguin MDI 1 morePenguin RFA | 2017 |
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
Integration Diagnostics Sweden 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: Tellos Medical AB (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Jan 2016 | K143445 | Tellos ISQ Buddy | Tellos Medical AB | EKX Ac-Powered Direct Drive Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INTEGRATION DIAGNOSTICS SWEDEN ABFDA reg. 3013206323 | Goteborg Vastra Gotaland, Sweden | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054105). 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.