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SleepRight
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 03543Model Select-ComfortRef 03521Model ProRxRef 03206Model Ultra-ComfortRef 03224Model Dura-ComfortRef 5568Model SR-SNORE-AID510(k) K172223
Identity
- Trade Name
- SleepRight EUDAMED
- Device Name
- SleepRight Select-Comfort Dental Guard EUDAMEDSleepRight ProRx Custom Dental Guard EUDAMEDSleepRight Ultra-Comfort Dental Guard EUDAMEDSleepRight Dura-Comfort Dental Guard EUDAMEDSleepRight Snore Aid EUDAMED
- Model / Reference
- Select-Comfort EUDAMED03543 EUDAMEDProRx EUDAMED03521 EUDAMEDUltra-Comfort EUDAMED03206 EUDAMEDDura-Comfort EUDAMED03224 EUDAMEDSR-SNORE-AID EUDAMED5568 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10692121035435 EUDAMED10692121035213 EUDAMED10692121032069 EUDAMED10692121032243 EUDAMED00692121035568 EUDAMED
- Basic UDI-DI
- 69212103543NP EUDAMED69212103521ND EUDAMED69212103206N2 EUDAMED69212103224N4 EUDAMED0692121SR-SNORE-AID6H EUDAMED
- 510(k) Number
- K172223 FDA 510(k)
- FDA Product Code
- OBR FDA 510(k)
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMEDV9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDU FDA 510(k)
- Market of Registration
- Estonia EUDAMEDNetherlands EUDAMED
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMEDEUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SleepRight by Splintek, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172223 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K250122 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69212103543NP | Class I | Active |
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Manufacturer
- Manufacturer
- Splintek, Inc.
- EUDAMED SRN
- US-MF-000012885
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (6)
- EUDAMED 74374228-4628-43c4-b888-8307afaf1716 61 fields · synced Aug 5, 2026
- EUDAMED b280f505-dd0a-4961-a8a8-8f1c67040caf 61 fields · synced May 17, 2026
- EUDAMED 474f3a7a-d772-4bf8-b56b-4860fe635d87 61 fields · synced May 17, 2026
- EUDAMED d9cd224e-7698-4da5-a841-4aae52583ad4 61 fields · synced May 18, 2026
- EUDAMED 0c60c41d-e2aa-4f8c-aec5-1554f5bcbefb 61 fields · synced May 18, 2026
- FDA 510(k) K172223 24 fields · synced May 18, 2026