Atlas FDA

EHL

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Point, Abrasive
Device class
Class I (low risk)
Regulation
21 CFR 872.6010
Medical specialty
Dental
Flags
GMP exempt
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RecordFirmDate
CUTTER POINTS (K792250)Cutter Laboratories, Inc.1980-01-23
DENTAL ABRASIVE DEVICE (K780811)Cavitron Corp.1978-06-22
MINIDENTOFLEX NEW POLISHING SYSTEM (K780376)Cavitron Corp.1978-03-14
PINIDENTOFLEX DENTAL POLISHER (K780377)Cavitron Corp.1978-03-14

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