FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 100
DI: D024772285
·
Model: 772285
·
Preventech
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1200
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Basic Information
- Brand Name
- VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 100
- Primary DI
- D024772285
- Version / Model
- 772285
- Catalog Number
- 772285
- Company Name
- Preventech
- Labeler DUNS
- 090735093
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1200
- Record Status
- Published
- Publish Date
- 2016-10-05
- Public Version
- 5
- Public Version Date
- 2024-06-14
- Public Version Status
- Update
- Public Device Record Key
- 4b62bdd1-e7e6-4b71-aef7-33e51e022844
- Distribution End Date
- 2021-05-31
Device Description
VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 100 ea. 0.5mL unit dose packages
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LBH | Varnish, Cavity | Dental | 872.3260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64794 | Dental coating, tooth-desensitizing, professional | A substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. 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 | D024772285 | HIBCC | ||||
| Unit of Use | D0247722855 | HIBCC |
Customer Contacts
- Phone
- 704-849-2416
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140350 | 000 |