Manufacturer registered with FDA
CM Instrumente GmbH
TUTTLINGEN, Germany. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 689 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name CM Instrumente GmbH 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 | CM Instrumente GmbH | 10 device types | — | Below |
| Peru | DIGEMID | Manufacturer | CM INSTRUMENTE GmbHCM INSTRUMENTE GMBH · CM-INSTRUMENTE GmbH | 80 | 2016–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | CM Instrumente GmbH | 6 | 2020–2020 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | CM INSTRUMENTE GMBH | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | CM Instrumente GmbH | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CM INSTRUMENTE GMBH | 1 | 2019–2019 | 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 CM Instrumente GmbH 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 | CM -InstrumenteCM ORTHODONTIC WIRE | 2006 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 2006 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | AND ACCESSORY INSTRUMENTSCM -InstrumentePINRETENTIVE AND SPLINTING | 2007 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | CM -InstrumenteCM DENTAL FORCEPS | 2006 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | CM -InstrumenteCM DENTAL SCISSORS | 2006 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 2006 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | CM -InstrumenteCM RUBBER DAM AND ACCESSORIES | 2006 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | — | 2006 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | — | 2006 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | CM -InstrumenteCM DENTAL ELEVATOR | 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 |
|---|---|---|
| CM INSTRUMENTE GMBHFDA reg. 9680518 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9009573). 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.