Identity
- Trade Name
- Smart Advantage GI Sample A1 and A2 pk FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Smart Advantage GI Sample A1 and A2 pk FDA UDI
- Model / Reference
- 675UD0200 FDA UDI
- Description
- Smart Advantage GI Sample A1 and A2 pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858290006444 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Smart Advantage GI Sample A1 and A2 pk by Elevate Oral Care, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Elevate Oral Care, LLC
Sources (1)
- FDA UDI ff491bcb-d84c-4c64-a7d9-45625a0623a6 34 fields · synced Jun 9, 2026