510(k) K252976
K252976 is an FDA 510(k) premarket notification submitted by Park Dental Research Corp. for the device "Park Dental Nylon MAD". The FDA issued a decision of Substantially Equivalent on December 18, 2025. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Park Dental Research Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2025
- Date Received
- September 17, 2025
- 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