The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Inclusive Tapered Implant System.
| Device ID | K153099 |
| 510k Number | K153099 |
| Device Name: | INCLUSIVE TAPERED IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE SUITE P Irvine, CA 92612 |
| Contact | Armin Zehtabchi |
| Correspondent | Armin Zehtabchi PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE SUITE P Irvine, CA 92612 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-26 |
| Decision Date | 2016-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701069IMP00140 | K153099 | 000 |
| D745701070IMP00330 | K153099 | 000 |
| D745701070IMP00340 | K153099 | 000 |
| D745701070IMP00350 | K153099 | 000 |
| D745701070IMP00360 | K153099 | 000 |
| D745701069IMP00100 | K153099 | 000 |
| D745701069IMP00110 | K153099 | 000 |
| D745701069IMP00120 | K153099 | 000 |
| D745701069IMP00130 | K153099 | 000 |
| D745701070IMP00320 | K153099 | 000 |