FDA UDI
In Commercial Distribution
🇺🇸 United States
Assure Plus
DI: 00817645020184
·
Model: 908R
·
Six Month Smiles
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Assure Plus
- Primary DI
- 00817645020184
- Version / Model
- 908R
- Company Name
- Six Month Smiles
- Labeler DUNS
- 118919669
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-05
- Public Version
- 2
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- 393441ca-49e7-4838-9a6b-7807eff483ea
Device Description
Assure Plus 2ml (Plus2ml)
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 |
|---|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | 872.3750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31750 | Orthodontic bracket adhesive | A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. 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 | 00817645020184 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K895522 | 000 |