Company ยท US
Splintek, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 2025 | K250122 | SleepRight Snore Aid Splintek, Inc. | LRK |
| Dec 22, 2021 | K212767 | SleepRight Select-Comfort Dental Guard Splintek, Inc. | MQC |
| Dec 13, 2021 | K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard Splintek, Inc. | OBR |
| Jun 1, 2020 | K193577 | SleepRight ProRx Custom Dental Guard Splintek, Inc. | OBR |
| Nov 17, 2017 | K172223 | SleepRight ProRx Custom Dental Guard Splintek, Inc. | OBR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||