Primeprint Splint ST 1000g
FDA UDIEUDAMEDClass I (US FDA UDI)
by DETAX GmbH
Identity
- Trade Name
- Primeprint Splint ST 1.000 g EUDAMEDPrimeprint Splint ST 1000g FDA UDI
- Generic Name
- Removable dental occlusal splint, custom-made FDA UDI
- Model / Reference
- 04415 EUDAMEDFDA UDIDental flexible Splints EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET044151 EUDAMEDEDET044151 FDA UDI
- Basic UDI-DI
- ++EDET1045K EUDAMED
- FDA Product Code
- DYJ FDA UDIKMY FDA UDIMQC FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Removable dental occlusal splint, custom-made FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI872.5525 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Removable dental occlusal splint, custom-made
Primeprint Splint ST 1000g by DETAX GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Removable dental occlusal splint, custom-made.
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- M-PM Crystal — Merz Dental GmbH · U
- IMPRIMO LC Splint comfort — Pro3Dure Medical · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DETAX GmbH
Sources (2)
- FDA UDI c6624457-b268-4d87-af96-abdfaff9bf4f 32 fields · synced Aug 2, 2026
- EUDAMED 1cd03e72-77c1-4dc6-9a7e-5437d84e6dc0 61 fields · synced Aug 2, 2026