The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Cad/camouflage Milling Bock.
| Device ID | K160425 |
| 510k Number | K160425 |
| Device Name: | CAD/CAMouflage Milling Bock |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Prismatik Dentalcraft, Inc. 2212 Dupont Drive, Suite P Irvine, CA 92612 |
| Contact | Armin Zehtabchi |
| Correspondent | Maria E. Wagner Prismatik Dentalcraft, Inc. 2212 Dupont Drive, Suite P Irvine, CA 92612 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701000CMN00331 | K160425 | 000 |
| D745701000CMN00130 | K160425 | 000 |
| D745701000CMN00120 | K160425 | 000 |
| D745701000CMN00110 | K160425 | 000 |
| D745701000CMN00100 | K160425 | 000 |
| D745701000CMN00090 | K160425 | 000 |
| D745701000CMN00080 | K160425 | 000 |
| D745701000CMN00070 | K160425 | 000 |
| D745701000CMN00060 | K160425 | 000 |
| D745701000CMN00050 | K160425 | 000 |
| D745701000CMN00040 | K160425 | 000 |
| D745701000CMN00030 | K160425 | 000 |
| D745701000CMN00020 | K160425 | 000 |
| D745701000CMN00140 | K160425 | 000 |
| D745701000CMN00150 | K160425 | 000 |
| D745701000CMN00160 | K160425 | 000 |
| D745701000CMN00280 | K160425 | 000 |
| D745701000CMN00270 | K160425 | 000 |
| D745701000CMN00260 | K160425 | 000 |
| D745701000CMN00250 | K160425 | 000 |
| D745701000CMN00240 | K160425 | 000 |
| D745701000CMN00230 | K160425 | 000 |
| D745701000CMN00220 | K160425 | 000 |
| D745701000CMN00210 | K160425 | 000 |
| D745701000CMN00200 | K160425 | 000 |
| D745701000CMN00190 | K160425 | 000 |
| D745701000CMN00180 | K160425 | 000 |
| D745701000CMN00170 | K160425 | 000 |
| D745701000CMN00010 | K160425 | 000 |