FDA UDI
In Commercial Distribution
🇺🇸 United States
Nu Alloy Caps. Jar X 500 - 1 Spill
DI: 07701126650973
·
Model: 87020
·
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nu Alloy Caps. Jar X 500 - 1 Spill
- Primary DI
- 07701126650973
- Version / Model
- 87020
- Catalog Number
- 87020
- Company Name
- PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- Labeler DUNS
- 880141023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a95ae767-9d91-4647-a1eb-bb3d4c10e83e
Device Description
Nu Alloy Caps. Jar X 500 - 1 Spill
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OIV | Dental Amalgam | Dental | 872.3070 | 2 |
| ELY | Mercury | Dental | 872.3070 | 2 |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 07701126650973 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140125 | 000 |