Identity
- Trade Name
- Ketac™ Fil Plus Aplicap™ FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- 3M™ ESPE™ Ketac™ Fil Plus Aplicap™ Glass Ionomer Restorative Intro Kit, 55000 FDA UDI
- Model / Reference
- 55000 FDA UDI
- Description
- 3M™ ESPE™ Ketac™ Fil Plus Aplicap™ Glass Ionomer Restorative Intro Kit, 55000 FDA UDI
Identifiers
- Catalog Number
- 55000 FDA UDI
- Primary DI / UDI-DI
- 04035077008969 FDA UDI
- FDA Product Code
- EMA FDA UDIKLE FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI872.3200 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
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: Dentine bonding agent/setGlass ionomer dental cementDental unfilled resin sealant/coatingDental material cartridge-plunging applicator, two-component, manual
Ketac™ Fil Plus Aplicap™ by 3M Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Deutschland GmbH
Sources (1)
- FDA UDI 7b455b75-62a2-4c85-8a78-cf140a103a19 35 fields · synced May 31, 2026