The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Inclusive Titanium Abutments Compatible With: Dentsply Implants Astra Tech Implant System Ev.
| Device ID | K191222 |
| 510k Number | K191222 |
| Device Name: | Inclusive Titanium Abutments Compatible With: Dentsply Implants Astra Tech Implant System EV |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Prismatik Dentalcraft, Inc. 2212 Dupont Drive, Suite P Irvine, CA 92612 |
| Contact | Herbert Schoenhoefer |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-07 |
| Decision Date | 2019-08-05 |