FDA UDI
In Commercial Distribution
🇺🇸 United States
Unison® Spherical Alloy
DI: D00265726131
·
Model: 657-2613
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Unison® Spherical Alloy
- Primary DI
- D00265726131
- Version / Model
- 657-2613
- Catalog Number
- 657-2613
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3e0785ce-fc13-41a1-a3cd-bff14e13f51b
Device Description
Unison® Spherical Alloy Self-Activating Capsules, 3 Spill, 500 (800mg) Beige/White caps
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 | D00265726132 | HIBCC | Case | 10 | In Commercial Distribution | |
| Primary | D00265726131 | HIBCC | ||||
| Unit of Use | D00265726130 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10 Jars of 50 Beige/White Capsules per box (800mg alloy each capsule) No.3 Spill |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a well-ventilated place and do not exceed 25 segrees Celsius.