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LUNE™ PureHygiene

Enamel Pure

Country / Region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

Summary PDF

Company

Enamel Pure
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K234085
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
2023-12-22
Decision date
2024-03-25
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
DentalOther
Primary application
Dental
Classification source
AI classified

Indications for Use

Enamel Pure LUNE PureHygiene is indicated for the following in dental hard tissue:
* Reduction of bacterial level (decontamination)

Intended Use

Enamel Pure LUNE PureHygiene is indicated for the following in dental hard tissue: * Reduction of bacterial level (decontamination)

Device Description

The subject LUNE PureHygiene is a mobile, cart-based dental treatment system comprised of a base console, a pneumatic footswitch, and handpieces that uses a pulsed CO2 laser energy to reduce/remove plaque and embedded carbonate from dental enamel.

Summary parsed at:2026-06-01 05:27:12 UTC

Predicate devices

2

K234085 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K234085 as a predicate