The following data is part of a premarket notification filed by Dental Direkt Gmbh with the FDA for Dd Cube One Ml.
| Device ID | K183569 |
| 510k Number | K183569 |
| Device Name: | DD Cube ONE ML |
| Classification | Powder, Porcelain |
| Applicant | Dental Direkt GmbH Industriezentrum 106-108 Spenge, DE 32139 |
| Contact | Uwe Greitens |
| Correspondent | Vera Escher Dental Direkt GmbH Industriezentrum 106-108 Spenge, DE 32139 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDDIG8220011 | K183569 | 000 |
| EDDIG8260051 | K183569 | 000 |
| EDDIG8260041 | K183569 | 000 |
| EDDIG8260031 | K183569 | 000 |
| EDDIG8260021 | K183569 | 000 |
| EDDIG8260011 | K183569 | 000 |
| EDDIG8250151 | K183569 | 000 |
| EDDIG8250101 | K183569 | 000 |
| EDDIG8250071 | K183569 | 000 |
| EDDIG8260071 | K183569 | 000 |
| EDDIG8260101 | K183569 | 000 |
| EDDIG8320071 | K183569 | 000 |
| EDDIG8320061 | K183569 | 000 |
| EDDIG8320051 | K183569 | 000 |
| EDDIG8320041 | K183569 | 000 |
| EDDIG8320031 | K183569 | 000 |
| EDDIG8320021 | K183569 | 000 |
| EDDIG8320011 | K183569 | 000 |
| EDDIG8260151 | K183569 | 000 |
| EDDIG8250051 | K183569 | 000 |
| EDDIG8250041 | K183569 | 000 |
| EDDIG8240011 | K183569 | 000 |
| EDDIG8220151 | K183569 | 000 |
| EDDIG8220101 | K183569 | 000 |
| EDDIG8220071 | K183569 | 000 |
| EDDIG8220051 | K183569 | 000 |
| EDDIG8220041 | K183569 | 000 |
| EDDIG8220031 | K183569 | 000 |
| EDDIG8220021 | K183569 | 000 |
| EDDIG8240021 | K183569 | 000 |
| EDDIG8240031 | K183569 | 000 |
| EDDIG8250031 | K183569 | 000 |
| EDDIG8250021 | K183569 | 000 |
| EDDIG8250011 | K183569 | 000 |
| EDDIG8240151 | K183569 | 000 |
| EDDIG8240101 | K183569 | 000 |
| EDDIG8240071 | K183569 | 000 |
| EDDIG8240051 | K183569 | 000 |
| EDDIG8240041 | K183569 | 000 |
| EDDIG8320081 | K183569 | 000 |
| EDDIG8320091 | K183569 | 000 |
| EDDIG8320101 | K183569 | 000 |
| EDDIG8360061 | K183569 | 000 |
| EDDIG8360051 | K183569 | 000 |
| EDDIG8360041 | K183569 | 000 |
| EDDIG8360031 | K183569 | 000 |
| EDDIG8360021 | K183569 | 000 |
| EDDIG8360011 | K183569 | 000 |
| EDDIG8340171 | K183569 | 000 |
| EDDIG8340161 | K183569 | 000 |
| EDDIG8360071 | K183569 | 000 |
| EDDIG8360081 | K183569 | 000 |
| EDDIG8360161 | K183569 | 000 |
| EDDIG8360151 | K183569 | 000 |
| EDDIG8360141 | K183569 | 000 |
| EDDIG8360131 | K183569 | 000 |
| EDDIG8360121 | K183569 | 000 |
| EDDIG8360111 | K183569 | 000 |
| EDDIG8360101 | K183569 | 000 |
| EDDIG8360091 | K183569 | 000 |
| EDDIG8340151 | K183569 | 000 |
| EDDIG8340141 | K183569 | 000 |
| EDDIG8340011 | K183569 | 000 |
| EDDIG8320171 | K183569 | 000 |
| EDDIG8320161 | K183569 | 000 |
| EDDIG8320151 | K183569 | 000 |
| EDDIG8320141 | K183569 | 000 |
| EDDIG8320131 | K183569 | 000 |
| EDDIG8320121 | K183569 | 000 |
| EDDIG8320111 | K183569 | 000 |
| EDDIG8340031 | K183569 | 000 |
| EDDIG8340041 | K183569 | 000 |
| EDDIG8340131 | K183569 | 000 |
| EDDIG8340121 | K183569 | 000 |
| EDDIG8340111 | K183569 | 000 |
| EDDIG8340101 | K183569 | 000 |
| EDDIG8340091 | K183569 | 000 |
| EDDIG8340081 | K183569 | 000 |
| EDDIG8340061 | K183569 | 000 |
| EDDIG8340051 | K183569 | 000 |
| EDDIG8360171 | K183569 | 000 |