Atlas FDA

EHO

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Bar, Preformed
Device class
Class I (low risk)
Regulation
21 CFR 872.3165
Medical specialty
Dental
Adverse events (MAUDE)
1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SLIP-ON FIXATION SPLINT (SFS) (K934468)Gatewood Splints1994-08-05
70-X/RVG (RADIOVISIOGRAPHY) (K881133)Trophy Radiologie1989-07-20
DENTREK BRIDGE BARS (K883388)Dale T. Dupuis1988-10-06

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