Identity
- Trade Name
- SPLINT MESH STAINLESS STEEL MESH ROLL FDA UDI
- Generic Name
- Removable dental occlusal splint, preformed FDA UDI
- Device Name
- SPLINT MESH STAINLESS STEEL MESH-39"ROLL FDA UDI
- Model / Reference
- ESG117 FDA UDI
- Description
- SPLINT MESH STAINLESS STEEL MESH-39"ROLL FDA UDI
Identifiers
- Catalog Number
- ESG117 FDA UDI
- Primary DI / UDI-DI
- 00841494104696 FDA UDI
- FDA Product Code
- EBL FDA UDI
- GMDN Term
- Removable dental occlusal splint, preformed FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3740 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
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
Category: Removable dental occlusal splint, preformed
Splint Mesh Stainless Steel Mesh Roll by Cynosure, LLC — Class I — 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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- Pink EF Series, Splint — Modern Dental Laboratory (DG) Co., Ltd. · Class II
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
- Cynosure, LLC
Sources (1)
- FDA UDI 4f400116-4da6-4797-ac14-54d09105654b 34 fields · synced May 31, 2026