FDA UDI
In Commercial Distribution
🇺🇸 United States
FluoriMax BubbleGum
DI: 00858290006123
·
Model: Flow Through Ampoule
·
ELEVATE ORAL CARE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
70
Basic Information
- Brand Name
- FluoriMax BubbleGum
- Primary DI
- 00858290006123
- Version / Model
- Flow Through Ampoule
- Company Name
- ELEVATE ORAL CARE, LLC
- Labeler DUNS
- 002863526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 70
- Record Status
- Published
- Publish Date
- 2016-10-01
- Public Version
- 4
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- b457750f-48ac-49cd-9c51-fa8cfaa1f1f2
Device Description
FluoriMax 2.5% NaF Varnish Flow Through Unit Dose 70pk
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 |
|---|---|---|---|---|
| 45232 | Dental coating, tooth-desensitizing | A substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and 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., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. 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 | 00858290006123 | GS1 | ||||
| Unit of Use | 00858290006154 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131376 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.4 | Milliliter |