The following data is part of a premarket notification filed by Oxy2plus, Llc with the FDA for Dentilube Spray.
| Device ID | K202689 |
| 510k Number | K202689 |
| Device Name: | Dentilube Spray |
| Classification | Saliva, Artificial |
| Applicant | Oxy2plus, LLC 4120 Rosemead Blvd Rosemead, CA 91770 |
| Contact | Chun Nan Lin |
| Correspondent | Chun Nan Lin Oxy2plus, LLC 4120 Rosemead Blvd Rosemead, CA 91770 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-15 |
| Decision Date | 2021-09-03 |