Identity
- Trade Name
- M-PRINT Splint Flex FDA UDI
- Generic Name
- Removable dental occlusal splint, preformed FDA UDI
- Device Name
- M-PRINT Splint flex clear, 1000 g FDA UDI
- Model / Reference
- M-PRINT Splint flex clear, 1000 g FDA UDI
- Description
- M-PRINT Splint flex clear, 1000 g FDA UDI
Identifiers
- Catalog Number
- 1084051 FDA UDI
- Primary DI / UDI-DI
- D7091084051 FDA UDI
- FDA Product Code
- MQC FDA UDI
- GMDN Term
- Removable dental occlusal splint, preformed FDA UDI
Classification
- Device Class
- U 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
Category: Removable dental occlusal splint, preformed
M-PRINT Splint Flex by Merz Dental GmbH — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Removable dental occlusal splint, preformed.
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- Restoration, splint — Modern Dental Laboratory (DG) Co., Ltd. · N
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- PERF-GRID — Cynosure, LLC · Class I
- splint — Modern Dental Laboratory (DG) Co., Ltd. · N
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 U | Pending data |
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Manufacturer
- Manufacturer
- Merz Dental GmbH
Sources (1)
- FDA UDI f6f1018e-7f7f-494a-9343-b666e065a8aa 35 fields · synced May 30, 2026