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Enamel Pure

Country / Region:United States (US)

510(k) submissions

2

Latest clearance

2026-05-29

Product codes

1
GEX

Cited as predicate

0

Product areas

FDA product code distribution

510(k) submissions

2 total

Showing 12

K numberDevice nameDecision
K260138LUNE PureHygiene2026-05-29
K234085LUNE™ PureHygiene2024-03-25

Company profile

Canonical name
Enamel Pure
Country / Region
United States(US)
Address
17 Briden St. Worcester,  MA  01605

Predicate manufacturers

Companies whose devices this company cited as predicates

1

1 manufacturers

Citing manufacturers

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0

No citing manufacturers yet

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