FDA UDI
In Commercial Distribution
🇺🇸 United States
LUNE™ PureHygiene
DI: 00860013727000
·
Model: EN0000-110-00
·
ENAMEL PURE INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LUNE™ PureHygiene
- Primary DI
- 00860013727000
- Version / Model
- EN0000-110-00
- Company Name
- ENAMEL PURE INC
- Labeler DUNS
- 117461944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-14
- Public Version
- 1
- Public Version Date
- 2025-04-22
- Public Version Status
- New
- Public Device Record Key
- 1ead822c-2500-4d1a-bc6f-b54e52126eb4
Device Description
Console
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48103 | Dental photo-activated disinfection system | An assembly of devices designed to provide light-activated disinfection of hard/soft tissue within the oral cavity to eliminate bacteria during dental applications such as restorative, endodontic and periodontic procedures and for general oral disinfection. It typically includes an electrically-powered control unit, a handpiece, a light guide, light guide tips, and a mains power supply. It disinfects oral tissues through the application of a chemical agent (e.g., tolonium chloride) to selected tissue, tagging the bacteria, which is then activated by a light-emitting diode (LED) resulting in the release of singlet oxygen, rupture of the bacterial cell walls, and destruction of the microbes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860013727000 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234085 | 000 |