FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Megalloy®EZ Spherical Amalgam
DI: D0026030041
·
Model: 603004
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- Megalloy®EZ Spherical Amalgam
- Primary DI
- D0026030041
- Version / Model
- 603004
- Catalog Number
- 603004
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2023-03-27
- Public Version Status
- Update
- Public Device Record Key
- a2577eb7-7571-4b08-ab3b-797824edd815
- Distribution End Date
- 2023-02-10
Device Description
Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 1 Spill (Red)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJJ | Alloy, amalgam | Dental | 872.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34836 | Dental amalgam alloy | A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D0026030042 | HIBCC | Case | 10 | Not in Commercial Distribution | 2023-01-25 |
| Primary | D0026030041 | HIBCC | ||||
| Unit of Use | D0026030040 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 400 | Milligram | |
| Device Size Text, specify | No. 1 Spill (Red): 10 jars of 50 Capsules (400mg alloy each capsule) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius