Splintek, Inc.
Splintek, Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 19, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 4
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K250122 | SleepRight Snore Aid | May 19, 2025 |
| K212767 | SleepRight Select-Comfort Dental Guard | Dec 22, 2021 |
| K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard | Dec 13, 2021 |
| K193577 | SleepRight ProRx Custom Dental Guard | Jun 1, 2020 |
| K172223 | SleepRight ProRx Custom Dental Guard | Nov 17, 2017 |