Manufacturer registered with FDA
LM-Instruments Oy
PARAINEN, Finland. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 26
- 510(k) clearances
- 0as applicant
- Markets registered in
- 111,489 registrations outside the US
- Establishments
- 1Finland
Registered in 11 markets
Where regulators' registries name LM-Instruments Oy 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 | LM-Instruments Oy | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | LM-Instruments Oy | 890 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | LM INSTRUMENTS S.A.LM-INSTRUMENTS OY | 464 | — | Pure Global AI |
| Australia | TGA | Manufacturer | LM-Instruments Oy | 44 | 2007–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | LM-INSTRUMENTS OY | 26 | 2011–2013 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | LM-Instruments Oy | 25 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | LM-Instruments OYLM-Instruments Oy · LM Instruments OY · +1 | 23 | 2000–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LM-INSTRUMENTS OY | 8 | 2006–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | LM-INSTRUMENTS OY | 4 | 2011–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | LM-Instruments OyLM INSTRUMENTS | 4 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | LM-Instruments Oy | 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 LM-Instruments Oy currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | LMArteLMDentalLMErgoAccessLMErgoMaxLMErgoMixLMErgoNormLMErgoSenseLMErgoSense Dark DiamondLMErgoSingleSoftGrip | 2013 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | — | 2013 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | ErgoAccessErgoMixLM-DENTALLM-LiftOutLM-RootOutLM-SlimLiftLM-TwistOutSoftGrip | 2003 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | — | 2013 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | LM-LiftOutLM-RootOutLM-SlimLiftLM-TwistOut | 2013 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | LM-ActivatorLM-Activator2LM-DentalLM-Trainer | 2006 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LM-INSTRUMENTS OYFDA reg. 8032033 | PARAINEN Varsinais-Suomi, Finland | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8032033). 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.