FDA UDI
In Commercial Distribution
🇺🇸 United States
Dentastic UNO
DI: D701UNOR2
·
Model: UNOR
·
PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dentastic UNO
- Primary DI
- D701UNOR2
- Version / Model
- UNOR
- Company Name
- PULPDENT CORPORATION
- Labeler DUNS
- 001006089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d0eaec01-0f24-444d-b3b6-f896ca3734a9
Device Description
6 mL bottle
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
- 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 |
|---|---|---|---|---|
| EMA | Cement, Dental | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42483 | Dentine adhesive | A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D701UNOR2 | HIBCC |