The following data is part of a premarket notification filed by Creodent Prosthetics, Ltd. with the FDA for Creodent Solidex Customized Abutment And Screw.
| Device ID | K202095 |
| 510k Number | K202095 |
| Device Name: | CreoDent Solidex Customized Abutment And Screw |
| 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 | 2020-07-29 |
| Decision Date | 2020-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D124SS65SCA0 | K202095 | 000 |
| D124SS48AS50 | K202095 | 000 |
| D124SS48S100 | K202095 | 000 |
| D124SS48S50 | K202095 | 000 |
| D124SS65S100 | K202095 | 000 |
| D124SS65S50 | K202095 | 000 |
| D124SS480 | K202095 | 000 |
| D124SS48AS0 | K202095 | 000 |
| D124SS48B140 | K202095 | 000 |
| D124SS48BL0 | K202095 | 000 |
| D124SS48S0 | K202095 | 000 |
| D124SS650 | K202095 | 000 |
| D124SS65B140 | K202095 | 000 |
| D124SS65BL0 | K202095 | 000 |
| D124SS65S0 | K202095 | 000 |
| D124SS48SCA0 | K202095 | 000 |
| D124SS48AS100 | K202095 | 000 |