Identity
- Trade Name
- Primeprint Guide FDA UDI
- Generic Name
- Removable dental occlusal splint, custom-made FDA UDI
- Model / Reference
- 02710 FDA UDI
Identifiers
- Primary DI / UDI-DI
- EDET027101 FDA UDI
- FDA Product Code
- KMY FDA UDINDP FDA UDIDYJ FDA UDIDYT FDA UDI
- GMDN Term
- Removable dental occlusal splint, custom-made FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 FDA UDI872.3980 FDA UDI872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Removable dental occlusal splint, custom-made
Primeprint Guide by DETAX GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Removable dental occlusal splint, custom-made.
- ProPlan CMF — Materialise NV · Class I
- M-PM Crystal — Merz Dental GmbH · U
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Vertex-Dental BV — Vertex-Dental B.V. · Class I
- M-PM Crystal — Merz Dental GmbH · U
- M-PM Crystal — Merz Dental GmbH · U
- IMPRIMO LC Splint comfort — Pro3Dure Medical · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DETAX GmbH
Sources (1)
- FDA UDI 2ea7401f-292b-4f12-b0a9-0489e5a05c95 32 fields · synced May 30, 2026