510(k) K221322
K221322 is an FDA 510(k) premarket notification submitted by Dental Choice Holdings, LLC for the device "CUSTMBITE Snoring System". The FDA issued a decision of Substantially Equivalent on October 27, 2022. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Dental Choice Holdings, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2022
- Date Received
- May 6, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type