Identity
- Trade Name
- ProPlan CMF FDA UDI
- Generic Name
- Removable dental occlusal splint, custom-made FDA UDI
- Device Name
- Splint and Planning Kit, Orthognathic Kit, one Splint FDA UDI
- Model / Reference
- SD900.009 FDA UDI
- Description
- Splint and Planning Kit, Orthognathic Kit, one Splint FDA UDI
Identifiers
- Catalog Number
- SD900.009 FDA UDI
- Primary DI / UDI-DI
- 05420060350580 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Removable dental occlusal splint, custom-made FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Removable dental occlusal splint, custom-made
ProPlan CMF by Materialise NV — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Removable dental occlusal splint, custom-made.
- Primeprint Splint SF 1000g — DETAX GmbH · Class I
- M-PM Crystal — Merz Dental GmbH · U
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Freeprint ortho 405 1000g — DETAX GmbH · 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
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
- Materialise NV
Sources (1)
- FDA UDI ad0fe47a-863a-4881-a939-f591f5eaa8cf 34 fields · synced Jun 6, 2026