Atlas FDA

EIK

5 FDA 510(k) clearances · Product code

80 daysmedian time to decision
195 days90th percentile
5clearances measured

FDA profile

Official device name
Carver, Wax, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Medical specialty
Dental
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
NEOCALEX (K013993)Stephen M Koral, Dmd2002-02-22
PERIO CONTROL II (K972642)Estrad B.V.1998-01-26
PDS-2000 (K902653)Intl. Equipment and Supply Corp.1990-09-13
ROOT CANAL ORGANIZER (K860817)Pacific Union Dental, Inc.1986-03-17
2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA (K851727)Artiberia1985-07-02

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