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EMI

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
File, Bone, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Medical specialty
Dental
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RecordFirmDate
MINI-MILL (K914035)Biomedical Composites, Ltd.1992-03-02
PLANUSTAR AND DENS NOBILIS DENTURE TEETH (K912989)Wilde-USA, Inc.1991-08-16
865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES (K851716)Artiberia1985-06-11
DISC NEEDLE SET #TX-8220 (K823676)Today'S Machining & Design, Inc.1983-01-09

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