510(k) K131396
K131396 is an FDA 510(k) premarket notification submitted by Elba Laboratories, Inc. for the device "WIRED MOUTH PROTECTOR (WMP)". The FDA issued a decision of Substantially Equivalent on September 30, 2013. The device falls under product code PFL (Intraoral, Dental Foam Protector), a Class I device regulated under 21 CFR 872.6890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2013
- Date Received
- May 15, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraoral, Dental Foam Protector
- Device Class
- Class I
- Regulation Number
- 872.6890
- Review Panel
- DE
- Submission Type
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.