Manufacturer registered with FDA
medmix Deutschland GmbH
Kiel, Germany. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 419 registrations outside the US
- Establishments
- 1Germany
Registered in 4 markets
Where regulators' registries name medmix Deutschland 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 | medmix Deutschland GmbH | 8 device types | — | Below |
| Canada | Health Canada | Registration holder | MEDMIX DEUTSCHLAND GMBH | 9 | 2012–2015 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | medmix Deutschland GmbH | 5 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | medmix Deutschland GmbH | 5 | — | 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 medmix Deutschland 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 |
|---|---|---|---|---|
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | GLUMA DESENSITIZER/GLUMA 3 PRIMERIBOND TOTAL ETCHiBond Universal & iBond Ceramic PrimerPrelude One UD | 2016 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | CRYSTALLINE C2 AND CRYSTALLINE L3iBond Universal & iBond Ceramic Primer | 2016 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | — | 2017 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Painless Steel | 2016 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Endo Evacuation NeedlesEndo Irrigation NeedlesFlexible Steel Endo Irrigation NeedlesSuction Needles | 2016 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | — | 2017 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | IBOND TOTAL ETCH | 2025 |
| Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR · Class 2 | — | Lister | — | 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
medmix Deutschland GmbH 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: Cooley Consulting, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Jul 2014 | K102973 | SILVER DENTAL ARREST | Cooley Consulting, Inc. | PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| medmix Deutschland GmbHFDA reg. 3007113445 | Kiel Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053472). 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.