Manufacturer
Enamel PureLUNE PureHygiene
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260138
- Device name
- LUNE PureHygiene
- Company
- Enamel Pure
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2026-01-16
- Decision date
- 2026-05-29
- Submission type
- Traditional
Predicate devices
0No predicate K numbers were extracted
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Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260138 as a predicate