The following data is part of a premarket notification filed by Creodent Prosthetics, Ltd. with the FDA for Creodent Solidex Customized Abutment.
| Device ID | K162734 |
| 510k Number | K162734 |
| 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 | 2016-09-30 |
| Decision Date | 2017-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D124CL50SB0 | K162734 | 000 |
| D124CL38SCA0 | K162734 | 000 |
| D124CL33SCA0 | K162734 | 000 |
| D124CL50SB50 | K162734 | 000 |
| D124CL50SB100 | K162734 | 000 |
| D124CL50AS50 | K162734 | 000 |
| D124CL50AS100 | K162734 | 000 |
| D124CL33S50 | K162734 | 000 |
| D124CL33S100 | K162734 | 000 |
| D124CL33AS50 | K162734 | 000 |
| D124CL33AS100 | K162734 | 000 |
| D124CL43SCA0 | K162734 | 000 |
| D124CL50SCA0 | K162734 | 000 |
| D124CL50BL0 | K162734 | 000 |
| D124CL50AS0 | K162734 | 000 |
| D124CL43BL0 | K162734 | 000 |
| D124CL430 | K162734 | 000 |
| D124CL38BL0 | K162734 | 000 |
| D124CL380 | K162734 | 000 |
| D124CL33S0 | K162734 | 000 |
| D124CL33BL0 | K162734 | 000 |
| D124CL33AS0 | K162734 | 000 |
| D124CL330 | K162734 | 000 |
| D124CL500 | K162734 | 000 |