The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Multi-unit Abutments With Angulations 17 And 30 For Tapered Implant System.
| Device ID | K121688 |
| 510k Number | K121688 |
| Device Name: | MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR., ST P Irvine, CA 92612 |
| Contact | Kathleen Dragovich |
| Correspondent | Kathleen Dragovich PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR., ST P Irvine, CA 92612 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-07 |
| Decision Date | 2012-10-12 |
| Summary: | summary |