The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Inclusive Titanium Abutments Compatible With: Megagen Anyridge Implant System.
| Device ID | K170044 |
| 510k Number | K170044 |
| Device Name: | Inclusive Titanium Abutments Compatible With: MegaGen AnyRidge Implant System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR. Irvine, CA 92612 |
| Contact | Maria E. Wagner |
| Correspondent | Maria E. Wagner PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR. 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 | 2017-01-05 |
| Decision Date | 2017-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701173COM00570 | K170044 | 000 |
| D745701173COM00560 | K170044 | 000 |