The following data is part of a premarket notification filed by Dental Direkt Gmbh with the FDA for Dd Contrast.
| Device ID | K193588 |
| 510k Number | K193588 |
| Device Name: | DD Contrast |
| Classification | Powder, Porcelain |
| Applicant | Dental Direkt GmbH Industriezentrum 106-108 Spenge, DE 32139 |
| Contact | Uwe Greitens |
| Correspondent | Patrick Berz Dental Direkt GmbH Industriezentrum 106-108 Spenge, DE 32139 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDDIDDCTTWF1 | K193588 | 000 |
| EDDIDDCCVA1 | K193588 | 000 |
| EDDIDDCCTR1 | K193588 | 000 |
| EDDIDDCCOR1 | K193588 | 000 |
| EDDIDDCCMP1 | K193588 | 000 |
| EDDIDDCCMM1 | K193588 | 000 |
| EDDIDDCCMC1 | K193588 | 000 |
| EDDIDDCCLG1 | K193588 | 000 |
| EDDIDDCCHA1 | K193588 | 000 |
| EDDIDDCCFI1 | K193588 | 000 |
| EDDIDDCCDG1 | K193588 | 000 |
| EDDIDDCCDD1 | K193588 | 000 |
| EDDIDDCCDC1 | K193588 | 000 |
| EDDIDDCCDB1 | K193588 | 000 |
| EDDIDDCCDA1 | K193588 | 000 |
| EDDIDDCCCE1 | K193588 | 000 |
| EDDIDDCCVI1 | K193588 | 000 |
| EDDIDDCCWH1 | K193588 | 000 |
| EDDIDDCTRE1 | K193588 | 000 |
| EDDIDDCTOB1 | K193588 | 000 |
| EDDIDDCTMA1 | K193588 | 000 |
| EDDIDDCTLI1 | K193588 | 000 |
| EDDIDDCTIL1 | K193588 | 000 |
| EDDIDDCTEB1 | K193588 | 000 |
| EDDIDDCTE591 | K193588 | 000 |
| EDDIDDCTCDB41 | K193588 | 000 |
| EDDIDDCTCDA11 | K193588 | 000 |
| EDDIDDCTCA1 | K193588 | 000 |
| EDDIDDCTBD1 | K193588 | 000 |
| EDDIDDCSLI1 | K193588 | 000 |
| EDDIDDCSET1 | K193588 | 000 |
| EDDIDDCGCF1 | K193588 | 000 |
| EDDIDDCGC1 | K193588 | 000 |
| EDDIDDCCBL1 | K193588 | 000 |