Atlas FDA

QGO

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Composite Resin Warmer
Device class
Class I (low risk)
Regulation
21 CFR 872.6100
Medical specialty
Dental
FDA definition
Intended to warm composite materials prior to use
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RecordFirmDate
Compex HD (K182017)Addent, Inc.2019-04-29

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