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EBE

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Coating, Denture Hydrophilic, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3300
Medical specialty
Dental
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RecordFirmDate
CS-11 (K832500)Chema-Scutum, Inc.1983-10-27
JOHNSON & JOHNSON OPAQUE COLOR MODIFI (K830491)Johnson & Johnson Professionals, Inc.1983-03-17
CONCEPT II (K790339)Richardson Merrel, Inc.1979-07-17

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Every clearance here is in the API, with alerts when new ones post.