The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Inclusive Titanium Abutments Compatible With: Zimmer, Biomet 3i, And Nobel Biocare Implant.
| Device ID | K142115 |
| 510k Number | K142115 |
| Device Name: | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE P Irvine, CA 92612 |
| Contact | Brandon Shepard |
| Correspondent | Brandon Shepard PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE 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 | 2014-08-04 |
| Decision Date | 2014-11-13 |
| Summary: | summary |