FDA Registration
Active
🇺🇸 United States
ELEVATE ORAL CARE, LLC
Reg #: 3009603151
·
FEI: 3009603151
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
5
Classifications
6
Registration Details
- Registration Name
- ELEVATE ORAL CARE, LLC
- Registration Number
- 3009603151
- FEI Number
- 3009603151
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 346 Pike Rd Ste 1 5 13 & 23
- City
- West Palm Beach
- State
- FL
- ZIP
- 33411
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150074
Owner / Operator
- Firm Name
- Elevate Oral Care
- Operator Number
- 10041046
- Address
- 346 Pike Road, Suite 1, 5, 13, & 23
- City
- West Palm Beach
- State
- FL
- Postal Code
- 33411
- Country
- US
- Correspondent
- Teri Sturgell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2015-03-12 |
| Saliva, Artificial | LFD | Class U | Unknown | No | 2018-09-12 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2026-03-02 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2014-09-15 |
| Diammine Silver Fluoride Dental Hypersensitivity Varnish | PHR | Class 2 | Dental | No | 2015-04-22 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2024-11-22 |
Proprietary Names
Epic Tongue Cleaner
Allday Dry Mouth Spray
Allday Dry Mouth Gel
Hybenx
FluoriMax
Advantage Arrest
Advantage Arrest Unit Dose
Advantage Arrest Gel
PapaCarie Duo
Advantage Arrest Silver Diamine Fluoride 38% and FluoriMax 2.5% Sodium Fluoride Varnish Convenience Kit
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Remanufacture Medical Device