Chrysalis Intelligence · Sponsors · Splintek, Inc.

Splintek, Inc.

Lenexa, KS, US · 4 510(k) clearances

Total clearances
4
2020-06-01 → 2025-05-19
Last 12 months
0
Product codes
3
Most recent
2025-05-19
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OBR 2 2021-12-13
LRK Device, Anti-Snoring Class II Dental 1 2025-05-19
MQC 1 2021-12-22
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-05-19 K250122 SleepRight Snore Aid LRK Class II Dental
2021-12-22 K212767 SleepRight Select-Comfort Dental Guard MQC
2021-12-13 K212706 SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard OBR
2020-06-01 K193577 SleepRight ProRx Custom Dental Guard OBR