FDA.reportPublic FDA data

LUNE™ PureHygiene

Primary DI
00860013727000
Brand
LUNE™ PureHygiene
Company
ENAMEL PURE INC
Model
EN0000-110-00
Device description
Console
Published
2025-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234085000LUNE™ PureHygieneEnamel Pure2024-03-25GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013727000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013727000008600137270008600137270000860013727000

GMDN Terms#

Term, Definition table
TermDefinition
Dental photo-activated disinfection systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117461944
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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