Data / Medical devices / Germany / medmix Deutschland GmbH
medmix Deutschland GmbH: FDA-registered device maker in Kiel Schleswig-Holstein, Germany, 1 510(k) clearance
medmix Deutschland GmbH is registered with the FDA (registration 3007113445) in Kiel Schleswig-Holstein, Germany. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 31, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007113445
- Address
- Zum Kesselort 53, Kiel Schleswig-Holstein, Germany, 24149
- Owner or operator
- medmix Deutschland GmbH (10053472)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 8, 2016
- Registered through
- 2026
- Brand names listed
- CRYSTALLINE C2 AND CRYSTALLINE L3, Endo Evacuation Needles, Endo Irrigation Needles, Flexible Steel Endo Irrigation Needles, GLUMA DESENSITIZER/GLUMA 3 PRIMER, IBOND TOTAL ETCH, Painless Steel, Prelude One UD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Contract manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Contract manufacturer | accessdata.fda.gov |
| Cord, Retraction | MVL | U | Contract manufacturer | accessdata.fda.gov |
| Diammine Silver Fluoride Dental Hypersensitivity Varnish | PHR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Contract manufacturer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2014 | K102973 | SILVER DENTAL ARREST | PHR | Substantially Equivalent | Cooley Consulting, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Adhesive, Bracket And Tooth Conditioner, Resin
- All makers of Diammine Silver Fluoride Dental Hypersensitivity Varnish
- All makers of Agent, Tooth Bonding, Resin
- All makers of Cord, Retraction
- All makers of Material, Tooth Shade, Resin
- All makers of Varnish, Cavity
Updated July 31, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.