The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Inclusive Mini Implant.
| Device ID | K100932 |
| 510k Number | K100932 |
| Device Name: | INCLUSIVE MINI IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PRISMATIK DENTALCRAFT, INC. 4141 MACARTHUR BLVD Newport Beach, CA 92660 |
| Contact | Keith Allred |
| Correspondent | Keith Allred PRISMATIK DENTALCRAFT, INC. 4141 MACARTHUR BLVD Newport Beach, CA 92660 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-05 |
| Decision Date | 2010-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701068IMP00090 | K100932 | 000 |
| D745701068IMP00080 | K100932 | 000 |
| D745701068IMP00070 | K100932 | 000 |
| D745701068IMP00060 | K100932 | 000 |
| D745701068IMP00050 | K100932 | 000 |
| D745701068IMP00040 | K100932 | 000 |
| D745701068IMP00030 | K100932 | 000 |
| D745701068IMP00020 | K100932 | 000 |
| D745701068IMP00010 | K100932 | 000 |