Identity
- Trade Name
- Vertex-Dental BV FDA UDI
- Generic Name
- Removable dental occlusal splint, custom-made FDA UDI
- Device Name
- For manufacturing 3d printed dental splints FDA UDI
- Model / Reference
- NDORBL01000_1 FDA UDI
- Description
- For manufacturing 3d printed dental splints FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719425509396 FDA UDI
- FDA Product Code
- DYT FDA UDI
- GMDN Term
- Removable dental occlusal splint, custom-made FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Category: Removable dental occlusal splint, custom-made
Vertex-Dental BV by Vertex-Dental B.V. — Class I — FDA UDI — listed in FDA GUDID — 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
- M-PM Crystal — Merz Dental GmbH · U
- IMPRIMO LC Splint comfort — Pro3Dure Medical · 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 |
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Manufacturer
- Manufacturer
- Vertex-Dental B.V.
Sources (1)
- FDA UDI b8368cea-6660-4854-a0c5-011a60af6065 33 fields · synced May 31, 2026