Atlas FDA

EKI

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Carrier, Amalgam, Operative
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Medical specialty
Dental
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RecordFirmDate
AMALGAM CARRIER (K945220)Buffalo Dental Mfg. Co., Inc.1995-01-11
PREMIER INLAY PLACER (K781034)Premier Dental Products Co.1978-06-30

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