Identity
- Trade Name
- Ultra High Copper Spherical FDA UDI
- Generic Name
- Dental amalgam FDA UDI
- Device Name
- Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 50 jar FDA UDI
- Model / Reference
- 55047 FDA UDI
- Description
- Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 50 jar FDA UDI
Identifiers
- Catalog Number
- 099-55047 FDA UDI
- Primary DI / UDI-DI
- D033099550471 FDA UDI
- 510(k) Number
- K951865 FDA UDI
- FDA Product Code
- EJJ FDA UDI
- GMDN Term
- Dental amalgam FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3070 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
Dimensions & Sizes
- Size
- Weight — 800 Milligram FDA UDI
Category: Dental amalgam
Ultra High Copper Spherical by DMG America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental amalgam.
- Spherodon + — SILMET LTD · Class II
- Original D Capsules 1 Spill Fast Set 500 count — WYKLE RESEARCH, INC. · Class II
- ANA 2000 Capsules 2 Spill 450 count — WYKLE RESEARCH, INC. · Class II
- Spherodon M Econom — SILMET LTD · Class II
- Stratosphere — HENRY SCHEIN, INC. · Class II
- Original D 1 spill amalgam regular set sample pack — WYKLE RESEARCH, INC. · Class II
- ANA 70 Capsules 1 Spill 450 count — WYKLE RESEARCH, INC. · Class II
- Dispersed Phase Alloy CAP Fast Set 2 SPILL — DARBY DENTAL SUPPLY, LLC · Class II
Cleared under the same submission
K951865 also covers:
- Formula-T Spherical Alloy — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy Fast Set 1 SPILL — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy Fast Set 2 SPILL — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy Fast Set 3 SPILL — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy Fast Set 3 SPILL — DARBY DENTAL SUPPLY, LLC
- Ultra High Copper Spherical — DMG America LLC
- Ultra High Copper Spherical — DMG America LLC
- Ultra High Copper Spherical — DMG America LLC
- Ultra High Copper Spherical — DMG America LLC
- Ultra High Copper Spherical — DMG America LLC
- ZenithDental Type-T High Copper Spherical — DMG America LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DMG America LLC
Sources (1)
- FDA UDI 65e8c66f-e7ac-417a-a2f0-1f11da0f7d8e 38 fields · synced May 30, 2026