Identity
- Trade Name
- Denture, splint FDA UDI
- Generic Name
- Partial denture FDA UDI
- Model / Reference
- 316 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972677873161 FDA UDI
- FDA Product Code
- NSK FDA UDINSL FDA UDINSR FDA UDI
- GMDN Term
- Partial denture 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: Partial dentureOrthodontic retainerComplete upper dentureComplete lower denture
Denture, splint by Modern Dental Laboratory (DG) Co., Ltd. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Removable dental occlusal splint, preformed.
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- The TMJ System™ — Myofunctional Research Corp. Pty. , Ltd. · Class I
- 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 74f896f4-e256-49d1-9635-20f97517cfc5 32 fields · synced May 31, 2026