FDA UDI
In Commercial Distribution
🇺🇸 United States
Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules
DI: D00265628631
·
Model: 656-2863
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules
- Primary DI
- D00265628631
- Version / Model
- 656-2863
- Catalog Number
- 656-2863
- 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
- 08ea4d04-09e1-4832-9f76-6aaf4bbede90
Device Description
Dispersed Phase Alloy, Fast Set, 3 Spill, 500 (800mg) Yellow 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
- Yes
- 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 | D00265628632 | HIBCC | Case | 10 | In Commercial Distribution | |
| Primary | D00265628631 | HIBCC | ||||
| Unit of Use | D00265628630 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Fast Set, 3 Spill, 10 cartons of 50 (800mg) Yellow caps | ||
| Weight | 800 | Milligram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.