Atlas FDA

KHR

10 FDA 510(k) clearances · Product code

50 daysmedian time to decision
90 days90th percentile
10clearances measured

FDA profile

Official device name
Absorber, Saliva, Paper
Device class
Class I (low risk)
Regulation
21 CFR 872.6050
Medical specialty
Dental
Flags
GMP exempt
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 (K980783)Irt Management Corp.1998-04-21
GENERAL HYGIENE KIT (K954068)Physician Industries, Inc.1995-11-08
GAUZE SPONGE (K953812)Remington Medical, Inc.1995-10-02
NON-STERILE GAUZE SPONGE (K891054)Dispomed, Inc.1989-05-01
ORTHODONTIC COTTON ROLL HOLDERS (K891354)American Orthodontics1989-04-17
DRY TIPS (K890734)Microcopy, Div. Neo-Flo, Inc.1989-03-10
ALGINATE WOOL FIBER (K870383)Adri1987-04-30
BOVO MOISTURE GUARD (K850988)E.H. Medical Co.1985-04-16
DEN-Z-ORB (K780400)Nice-Pak Products, Inc.1978-03-27
ISO-SHIELD SALIVA ABSORBERS (K771908)3M Company1977-11-07

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