FDA.reportPublic FDA data

Splintek Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30034601513003322666Splintek Inc.1N2026-01-0115555 W 108th Street Lenexa KS US 66219

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00692121035216SleepRight - SleepRight ProRx Custom-Fit Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.888-792-0865support@splintek.com
00692121035513SleepRight - SleepRight Snore Aid is intended for use by adult patients 18 years of age or older as an aid for the reduction of snoring.888-792-0865support@splintek.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
596701489715345K250122SleepRight Snore AidLRK2025-05-19
596701541876525K172223SleepRight ProRx Custom Dental GuardOBR2017-11-17
596701025341571K071404SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCEMQC2007-08-17
596701491777283
596701539124287

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK12025-05-19
OBR12017-11-17
MQC12007-08-17

GUDID#