Splintek Inc

FDA Filings

This page includes the latest FDA filings for Splintek Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003460151
• FEI Number: 3003322666
• Name: Splintek Inc.
• Owner & Operator: Splintek Inc.
• Contact Address: 15555 W 108th Street --; Lenexa KS 66219 US
• Official Correspondent:
  • Annie - Brown
  • 1-816-5312008-229
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 15555 W 108th Street ; Lenexa, KS 66219 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00692121035216 Splintek Inc.	SleepRight	2023-09-07
PMN K212767 Splintek, Inc.	SleepRight Select-Comfort Dental Guard	2021-12-22
PMN K193577 Splintek, Inc.	SleepRight ProRx Custom Dental Guard	2020-06-01
PMN K172223 Splintek, Inc.	SleepRight ProRx Custom Dental Guard	2017-11-17