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Spherodon +
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref O-130472Ref O-130473
by Silmet Ltd
Identity
- Trade Name
- Spherodon + EUDAMEDFDA UDISpherodon + FDA UDI
- Generic Name
- Dental amalgam FDA UDI
- Device Name
- Amalgams & Alloys EUDAMEDDental Amalgam Capsules FDA UDI
- Model / Reference
- O-130473 EUDAMEDFDA UDIO-130472 EUDAMEDFDA UDIO-130493 FDA UDI
- Description
- Dental Amalgam Capsules FDA UDI
Identifiers
- Catalog Number
- O-130493 FDA UDIO-130473 FDA UDIO-130472 FDA UDI
- Primary DI / UDI-DI
- 07290012207532 EUDAMEDFDA UDI07290012207525 EUDAMEDFDA UDI07290012207594 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
Spherodon + 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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- Ionosphere — HENRY SCHEIN, INC. · Class II
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 8c742593-55ec-442c-be55-51d77116513e 34 fields · synced Jul 9, 2026
- FDA UDI ef6a19fd-7860-4a6f-8b0c-e1949b5de384 34 fields · synced May 29, 2026
- FDA UDI 884fb907-25ab-484a-bcf6-376d8548a589 34 fields · synced May 30, 2026
- EUDAMED 5740fff6-f490-4f42-99c6-b596b4055abc 61 fields · synced Jun 20, 2026
- EUDAMED e969dae0-1ff7-45ef-b3d0-81ed856e5ec7 61 fields · synced Jul 9, 2026