LM-Instruments Oy
FI-MF-000006705 · Finland · Parainen
LM-Instruments Oy is registered in the European database on medical devices as a manufacturer, with 2 639 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 639 |
|---|
Most frequent device types declared: An endodontic hand instruments for root canal reparation, Dental hand instrument for implant insertion, Dental hand instrument, curette for the removal of the subgingival and, Dental hand instrument, curette for the removal of the supragingival c, Dental hand instrument, excavator for preparation of root canal.
Among these devices, 1 411 are declared reusable, 23 active.
Devices declared under this manufacturer
- Barnhart 5-6 SD DTS U
- Burnisher-Plugger 1.5-2.5mm ball-ended
- Explorer-Periodontal probe DTS U
- Form Condenser 1.5-2.5mm Orbis
- Furcation Probe
- Gracey 17/18 Mini
- LM-Dental 153768
- Micro Sickle SD DTS
- Mirror handle 28 Esi grey UNF4-48
- My LM-Activator 40 Low Short
- Nabers Probe
- Sickle LM23 SD
Showing 12 of 2 639 declared devices.
Catalogue references include 20B-21BES, 23-530BESTU, 247-248MXSI, 283MTIEM, 301-302SDEST, 471-473DDES.
European nomenclature codes declared: L159001, Q010499, Q01010199, Q0199, L159004, L159002.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LM-INSTRUMENTS OY (FI) · FDA 8032033 |
| Devices in EUDAMED | 2 639 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 2 639 |
|---|---|
| Found in the U.S. device database | 1 641 |
| Share | 62.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LM-INSTRUMENTS OY |
North American profile: Both markets. LM-Instruments Oy is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1080-826-23 | supplemented | 2028-09-11 |