This page includes the latest FDA filings for Zendo Direct Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3013885621 |
| FEI Number | 3013885621 |
| Name | Adriatik Mete |
| Owner & Operator | Zendo Direct AG |
| Contact Address | Zeughausgasse 18 Postbox 1225 Zug CH-ZG Zug 6301 CH |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 11629 49th Place West Mukilteo, WA 98275 US |
| Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
| Registration Number | 3011279053 |
| FEI Number | 3011279053 |
| Name | Zendo Direct USA |
| Owner & Operator | Zendo Direct AG |
| Contact Address | Zeughausgasse 18 Postbox 1225 Zug CH-ZG Zug 6301 CH |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 132 Huerta Place Davis, CA 95616 US |
| Establishment Type | Repack or Relabel Medical Device |
Device Company | Device | Date |
|---|---|---|
| Zendo Direct AG | Select Supratemp TCB-ST-A3 | 2018-05-07 |
| Zendo Direct AG | MTA-Flow Fast Set ZEN-MTA-FLOFST | 2018-03-29 |
| Zendo Direct AG | MTA Firm-Fast Set ZEN-MTA-FRMFSTSET | 2018-03-29 |
| Zendo Direct AG | MTA Firm- Normal Set ZEN-MTA-FRMNSET | 2018-03-29 |
| Zendo Direct AG | MTA Capsules ZEN-MTA-UNI | 2018-03-29 |
| Zendo Direct AG | Select Sil Medium Body SEL-SIL-MB-SHFS-PNK5 | 2018-03-29 |
| Zendo Direct AG | Select Sil Heavy Viscosity SEL-SIL-SHFS-GR50 | 2018-03-29 |
| Zendo Direct AG | Select Sil Light Body SEL-SIL-LB-SHFS-50 | 2018-03-29 |
| Zendo Direct AG | Select Calcium Hydroxide Liner LC CAL-LINER | 2018-03-29 |
| Zendo Direct AG | Select Transbite SELSIL-TRANS-B | 2018-03-29 |
| Zendo Direct AG | Select Sil Firm Putty SEL-SIL-FR-B400 | 2018-03-29 |
| Zendo Direct AG | Select NanoFill FIL-RC-A1 | 2018-03-29 |
| Zendo Direct AG | Select Flow SEL-LCFLOWA3 | 2018-03-29 |
| Zendo Direct AG | Select Flow SEL-LCFLOWA2 | 2018-03-29 |
| Zendo Direct AG | Select Flow SEL-LCFLOWA1 | 2018-03-29 |
| Zendo Direct AG | Select Sil Heavy Viscosity SEL-SIL-SHRS-GR50 | 2018-03-29 |
| Zendo Direct AG | Select Sil Medium Body SEL-SIL-MB-SHRS-PNK5 | 2018-03-29 |
| Zendo Direct AG | Select Sil Light Body SEL-SIL-LB-SHRS-50 | 2018-03-29 |
| Zendo Direct AG | Select SE-Bond LC SEL-ETCH-LC-5ml | 2018-03-29 |
| Zendo Direct AG | Select NanoFill FIL-RC-A2 | 2018-03-29 |
| Zendo Direct AG | Select NanoFill FIL-RS-A3 | 2018-03-29 |
| Zendo Direct AG | Select NanoFill FIL-RS-A2 | 2018-03-29 |
| Zendo Direct AG | Select NanoFill FIL-RS-A1 | 2018-03-29 |
| Zendo Direct AG | Select Rigid BR RIGBR-LB-SH | 2018-03-29 |