Identity
- Trade Name
- Restoration, splint FDA UDI
- Generic Name
- Custom-made dental crown, polymer FDA UDI
- Model / Reference
- 348 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972677873482 FDA UDI
- FDA Product Code
- NSN FDA UDINSP FDA UDINSR FDA UDI
- GMDN Term
- Custom-made dental crown, polymer FDA UDI
Classification
- Device Class
- N 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: Dental bridge, polymerOrthodontic retainerCustom-made dental crown, ceramicDental bridge, ceramic
Restoration, splint by Modern Dental Laboratory (DG) Co., Ltd. — Class N — 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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- MODUS — Medartis Inc. · Class I
- M-PRINT Splint Flex — Merz Dental GmbH · U
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 N | Pending data |
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Manufacturer
- Manufacturer
- Modern Dental Laboratory (DG) Co., Ltd.
Sources (1)
- FDA UDI 562b339d-1175-44c0-8080-4f8b4a50b42a 32 fields · synced May 30, 2026