Identity
- Trade Name
- Nogama EUDAMEDFDA UDI
- Generic Name
- Dental amalgam FDA UDI
- Device Name
- Amalgams & Alloys EUDAMEDDental Amalgam Capsules FDA UDI
- Model / Reference
- O-110471 EUDAMEDFDA UDIO-111309 FDA UDI
- Description
- Dental Amalgam Capsules FDA UDI
Identifiers
- Catalog Number
- O-111309 FDA UDIO-110471 FDA UDI
- Primary DI / UDI-DI
- 07290012207006 EUDAMEDFDA UDI07290016787634 FDA UDI
- Basic UDI-DI
- 7290011DMR1WQ EUDAMED
- FDA Product Code
- EJJ FDA UDI
- EMDN Code
- Q01010101 AMALGAMS FOR RESTORATIVE DENTISTRY EUDAMED
- GMDN Term
- Dental amalgam FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3070 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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: Dental amalgam
Nogama by Silmet Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental amalgam.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Silmet Ltd
Sources (3)
- FDA UDI 3ce1243d-6e97-41a1-a32c-63d40a317b40 34 fields · synced Jul 9, 2026
- FDA UDI b418fe17-3fa6-4dbe-8e41-28356a9e8cbc 34 fields · synced May 30, 2026
- EUDAMED c5ffe231-81e1-43f9-93ad-2a25d491eb31 61 fields · synced Jul 9, 2026