ORAMOIST
Saliva, Artificial
QUANTUM, INC.
The following data is part of a premarket notification filed by Quantum, Inc. with the FDA for Oramoist.
Pre-market Notification Details
| Device ID | K122663 |
| 510k Number | K122663 |
| Device Name: | ORAMOIST |
| Classification | Saliva, Artificial |
| Applicant | QUANTUM, INC. 7195 LONGVIEW DRIVE Cleveland, OH 44139 |
| Contact | Fred Ma |
| Correspondent | Fred Ma QUANTUM, INC. 7195 LONGVIEW DRIVE Cleveland, OH 44139 |
| 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 | 2012-08-31 |
| Decision Date | 2013-05-30 |
| Summary: | summary |
Trademark Results [ORAMOIST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORAMOIST 77195784 3778486 Live/Registered |
DENTEK ORAL CARE, INC. 2007-06-01 |
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