The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Cad/camouflage Milling Block.
| Device ID | K162537 |
| 510k Number | K162537 |
| Device Name: | CAD/CAMouflage Milling Block |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE P Irvine, CA 92612 |
| Contact | Aliva Das |
| Correspondent | Lisa Maloney PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE P Irvine, CA 92612 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-12 |
| Decision Date | 2016-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701000CMN00421 | K162537 | 000 |
| D745701000CMN00301 | K162537 | 000 |
| D745701000CMN00311 | K162537 | 000 |
| D745701000CMN00321 | K162537 | 000 |
| D745701000CMN00341 | K162537 | 000 |
| D745701000CMN00351 | K162537 | 000 |
| D745701000CMN00361 | K162537 | 000 |
| D745701000CMN00371 | K162537 | 000 |
| D745701000CMN00381 | K162537 | 000 |
| D745701000CMN00391 | K162537 | 000 |
| D745701000CMN00401 | K162537 | 000 |
| D745701000CMN00411 | K162537 | 000 |
| D745701000CMN00291 | K162537 | 000 |