The following data is part of a premarket notification filed by Dreve Dentamid Gmbh with the FDA for Dynax Clear, Dynax Putty, Dynax Heavy Body, Dynax Light, Dynax Mono.
| Device ID | K171562 |
| 510k Number | K171562 |
| Device Name: | Dynax Clear, Dynax Putty, Dynax Heavy Body, Dynax Light, Dynax Mono |
| Classification | Material, Impression |
| Applicant | Dreve Dentamid GmbH Max-Planck-StraBe 31 Unna, DE 59423 |
| Contact | Reiner Altmann |
| Correspondent | Richard Keen Dreve Dentamid GmbH 1151 Hope Street Stamford, CT 06907 -1659 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2018-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E239D918130071 | K171562 | 000 |
| E239D61031 | K171562 | 000 |
| E239D61041 | K171562 | 000 |
| E239D61061 | K171562 | 000 |
| E239D61071 | K171562 | 000 |
| E239D61121 | K171562 | 000 |
| E239D61131 | K171562 | 000 |
| E239D61211 | K171562 | 000 |
| E239D61221 | K171562 | 000 |
| E239D61011 | K171562 | 000 |