Identity
- Trade Name
- Ketac™ Molar Quick Aplicap™ FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- 3M™ ESPE™ Ketac™ Molar Quick Aplicap™ Glass Ionomer Restorative Shade A2 Refill, 56361 FDA UDI
- Model / Reference
- 56361 FDA UDI
- Description
- 3M™ ESPE™ Ketac™ Molar Quick Aplicap™ Glass Ionomer Restorative Shade A2 Refill, 56361 FDA UDI
Identifiers
- Catalog Number
- 56361 FDA UDI
- Primary DI / UDI-DI
- 04035077008822 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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 cement
Ketac™ Molar Quick Aplicap™ by 3M Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glass ionomer dental cement.
- KETAC™ — 3M COMPANY · Class II
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- SciPharm Until Temporary Crown and Bridge Cement — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
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- Vivid Glass Restorative A2 Std Pkg — PEARSON DENTAL SUPPLIES, INC. · Class II
- GC Fuji II LC® — Gc America Inc. · Class II
- GC Fuji LINING™ — Gc America Inc. · Class II
- 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 Deutschland GmbH
Sources (1)
- FDA UDI 87b4fb2f-6298-4b04-9a63-bbdab9765359 35 fields · synced Jun 1, 2026