The following data is part of a premarket notification filed by Creodent Prosthetics, Ltd. with the FDA for Creodent Solidex Customized Abutment.
| Device ID | K150012 |
| 510k Number | K150012 |
| Device Name: | CreoDent Solidex Customized Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | CREODENT PROSTHETICS, LTD. 29 WEST 30TH STREET, 11TH FLOOR New York, NY 10001 |
| Contact | Calvin Shim |
| Correspondent | Calvin Shim CREODENT PROSTHETICS LTD. 29 WEST 30TH STREET, 11TH FLOOR New York, NY 10001 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-05 |
| Decision Date | 2015-06-04 |
| Summary: | summary |