FDA UDI
In Commercial Distribution
🇺🇸 United States
FluoriMax Cotton Candy
DI: 00858290006734
·
Model: Flow Through Ampoule 70 pack
·
ELEVATE ORAL CARE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
70
Basic Information
- Brand Name
- FluoriMax Cotton Candy
- Primary DI
- 00858290006734
- Version / Model
- Flow Through Ampoule 70 pack
- Catalog Number
- 630007022
- Company Name
- ELEVATE ORAL CARE, LLC
- Labeler DUNS
- 002863526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 70
- Record Status
- Published
- Publish Date
- 2024-12-12
- Public Version
- 1
- Public Version Date
- 2024-12-20
- Public Version Status
- New
- Public Device Record Key
- 9887a476-4968-4322-a44b-e7826c014c51
Device Description
FluoriMax 2.5% NaF Varnish Cotton Candy Flavor flow through ampoules 70 pack
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
- 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 | 00858290006734 | GS1 | ||||
| Unit of Use | 00858290006925 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131376 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.4 | Milliliter |