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Spherodon - M
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref O-120471Ref O-120472
by Silmet Ltd
Identity
- Trade Name
- Spherodon M EUDAMEDSpherodon - M FDA UDI
- Generic Name
- Dental amalgam FDA UDI
- Device Name
- Amalgams & Alloys EUDAMEDDental Amalgam Capsules FDA UDI
- Model / Reference
- O-120471 EUDAMEDFDA UDIO-120472 EUDAMEDFDA UDI129471 FDA UDI
- Description
- Dental Amalgam Capsules FDA UDI
Identifiers
- Catalog Number
- O-120471 FDA UDI129471 FDA UDIO-120472 FDA UDI
- Primary DI / UDI-DI
- 07290012207303 EUDAMEDFDA UDI07290012207310 EUDAMEDFDA UDI07290012207426 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
- Romania EUDAMEDMalta 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
Spherodon - M 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 (5)
- FDA UDI d51995af-f513-406f-aeb4-505418353eaf 34 fields · synced Jul 30, 2026
- FDA UDI 1e909628-5ed2-4871-bc2b-6c3fc4437203 34 fields · synced May 25, 2026
- FDA UDI 463713df-8a02-4ba1-a732-d276ffd30de9 34 fields · synced May 30, 2026
- EUDAMED 7af8103f-1485-4d8c-9e0b-50a282de5250 61 fields · synced Jul 25, 2026
- EUDAMED a15e0d1e-8d40-4c25-ba5f-3139bb30c718 61 fields · synced Jul 30, 2026