Identity
- Trade Name
- KETAC™ FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- 3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Restorative Shade A3.5 Refill, 3304A3.5 FDA UDI
- Model / Reference
- 3304A3.5 FDA UDI
- Description
- 3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Restorative Shade A3.5 Refill, 3304A3.5 FDA UDI
Identifiers
- Catalog Number
- 3304A3.5 FDA UDI
- Primary DI / UDI-DI
- 30605861036390 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
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glass ionomer dental cement
Ketac™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Prontolute Glass Ionomer Luting Cement 30g — ADVANCED HEALTHCARE LTD. · Class IIa
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
- 3m Company
Sources (1)
- FDA UDI 32c82289-092d-4454-b9d4-5823083f4585 35 fields · synced May 30, 2026