The following data is part of a premarket notification filed by Oralabs, Inc. with the FDA for Oral B Plus Outlast Night Time Dental Guard.
| Device ID | K113326 |
| 510k Number | K113326 |
| Device Name: | ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD |
| Classification | Mouthguard, Over-the-counter |
| Applicant | ORALABS, INC. 18685 EAST PLAZA DRIVE Parker, CO 80134 |
| Contact | Teresa Purdue |
| Correspondent | Teresa Purdue ORALABS, INC. 18685 EAST PLAZA DRIVE Parker, CO 80134 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-10 |
| Decision Date | 2012-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D132MG0010 | K113326 | 000 |