Manufacturer registered with FDA
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma
RUDNIKI K/CZESTOCHOWY, Poland. Lists 18 dental device types with FDA across 1 registered establishment.
- Device types listed
- 18
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Poland
Devices listed with FDA
What Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Wire CHIRMED | 2006 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dental Needle CHIRMED | 2024 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth Mirror CHIRMED | 2014 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Orthodontic Ligature Tucking Instrument | 2014 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Dental Dressing Forceps CHIRMED | 1995 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Irrigating Dental Syringe CHIRMED | 2024 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Periodontic Probe CHIRMED | 2024 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Cartridge Syringe CHIRMED | 2024 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | Dental Operative Excavator CHIRMED | 2024 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Surgical Rongeur Forceps CHIRMED | 2024 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Surgical Dental Elevator CHIRMED | 2016 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Periodontic Scaler CHIRMED | 2024 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | Periodontic Knife CHIRMED | 2016 |
| Periodontic HoeEMQ · Class 1 | Dental hand instruments | Maker | Periodontic Hoe CHIRMED | 2016 |
| Restorative Instrument and Component TrayOFW · Class 2 | — | Maker | Restorative Instrument CHIRMED | 2024 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | General Purpose Dental Tray CHIRMED | 2024 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant Surgical Tray CHIRMED | 2024 |
| Oral Surgery TrayPWL · Class 1 | Dental hand instruments | Maker | Oral Surgery Tray CHIRMED | 2024 |
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 |
|---|---|---|
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka KomandytowaFDA reg. 3005587147 | RUDNIKI K/CZESTOCHOWY Slaskie, Poland | Manufacturer |
Other names on FDA records
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Komandytowa
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9023253). 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.