Identity
- Trade Name
- Ketac™ Cem Aplicap™ FDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, two-component, manual FDA UDI
- Device Name
- 3M™ ESPE™ Ketac™ Cem Aplicap™ Glass Ionomer Luting Cement Introductory Kit, 56053 FDA UDI
- Model / Reference
- 56053 FDA UDI
- Description
- 3M™ ESPE™ Ketac™ Cem Aplicap™ Glass Ionomer Luting Cement Introductory Kit, 56053 FDA UDI
Identifiers
- Catalog Number
- 56053 FDA UDI
- Primary DI / UDI-DI
- 04035077013093 FDA UDI
- FDA Product Code
- EID FDA UDIEMA FDA UDI
- GMDN Term
- Dental material cartridge-plunging applicator, two-component, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI872.3275 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: Glass ionomer dental cementDental material cartridge-plunging applicator, two-component, manual
Ketac™ Cem Aplicap™ by 3M Deutschland GmbH — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- 3M Deutschland GmbH
Sources (1)
- FDA UDI 52aeaf7e-945e-44c6-9aea-1c264abb639e 35 fields · synced Jun 6, 2026