Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Splintek, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated May 19, 2025: SleepRight Snore Aid.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 19, 2025 | SleepRight Snore AidK250122 · LRK | 510(k) clearances |
| Dec 22, 2021 | SleepRight Select-Comfort Dental GuardK212767 · MQC | 510(k) clearances |
| Dec 13, 2021 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardK212706 · OBR | 510(k) clearances |
| Jun 1, 2020 | SleepRight ProRx Custom Dental GuardK193577 · OBR | 510(k) clearances |
| Nov 17, 2017 | SleepRight ProRx Custom Dental GuardK172223 · OBR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
