The following data is part of a premarket notification filed by Rodo Medical, Inc. with the FDA for Rodo Smilekey.
| Device ID | K180609 |
| 510k Number | K180609 |
| Device Name: | Rodo Smilekey |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Rodo Medical, Inc. 6399 San Ignacio Ave., Suite 100 San Jose, CA 95119 |
| Contact | Michael Parsons |
| Correspondent | Randy Prebula Hogan Lovells US LLP 555 Thirteen Street NW Washington, DC 20004 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-08 |
| Decision Date | 2018-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816131021995 | K180609 | 000 |