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510(k) K071404

Device
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
Applicant
POWER PRODUCTS, INC.-SPLINTEK
510(k) number
K071404
Product code
MQC  
Decision
Substantially Equivalent (SESE)
Decision date
2007-08-17
Date received
2007-05-21
Regulation
510(k) Premarket Notification
Classification name
Mouthguard, Prescription
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MALANIE HASEK
Address
9755 Ridge Dr. Lenexa KS US 66219 66219

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.2026-03-02
K250743Remvia NightGuardRemvia2025-12-05
K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation2025-08-01
K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation2025-03-18
K243516Remi Custom Night GuardGrindguard, Inc.2025-02-10
K241369LIJIA Night GuardLijia, LLC2024-08-22
K231775GR Resin System MSIPro3Dure Medical2024-08-08
K241311Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)Bernhard Förster GmbH2024-08-02
K240463Slow Wave DS8 (SWDS802)Slow Wave, Inc.2024-06-04
K231793RODIN 3D Resin SPLINT, Hard/FlexBelport Company, Inc., Gingi-Pak2024-03-26
K232087Dental LT Comfort ResinFormlabs Ohio, Inc.2024-02-16
K230548Myoaligner ApplianceMyohealth Technologies, LLC2024-02-02
K230592LuxCreo Dental Night Guard ResinLuxCreo, Inc.2024-01-18
K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC2023-11-28
K230495Serena Sleep Night GuardMeris Investment Group2023-10-13

Legacy Summary#

summary

FDA Review#

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