510(k) K113326
K113326 is an FDA 510(k) premarket notification submitted by Oralabs, Inc. for the device "ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD". The FDA issued a decision of Substantially Equivalent on June 27, 2012. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device. Oralabs, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2012
- Date Received
- November 10, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Over-The-Counter
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.