Atlas FDA

JET

15 FDA 510(k) clearances · Product code

34 daysmedian time to decision
196 days90th percentile
15clearances measured

FDA profile

Official device name
Pick, Massaging
Device class
Class I (low risk)
Regulation
21 CFR 872.6650
Medical specialty
Dental
Flags
GMP exempt
Adverse events (MAUDE)
1999: 1 · 2022: 39 · 2023: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. (K963747)Whitehill Manufacturing, Inc.1996-12-16
ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE (K942633)Oral-B Laboratories1995-04-27
ELECTRO FLOSS (K930178)Arizona Implant Dentistry1993-07-28
GUM MASSAGER (K911418)Burn-Henderson Partnership1991-07-17
MASSAGING PICK FOR ORAL HYGIENE (K885189)Dentek Corp.1989-03-17
PLAKOF (K890910)Ximex, Ltd.1989-03-16
FLOSSIE (K883225)Richard G. Deniro1988-08-30
PERMA-PIC PLASTIC TOOTHPICK (K881900)The Perma-Pic Co.1988-06-01
SUPER PIK MASSAGING PICK FOR ORAL HYGIENE (K881046)U.S. Dentek Corp.1988-05-13
ULTRAPROX, INTERPROXIMAL TOOTHBRUSH (K860779)William J. Forni, D.D.S.1986-04-02
DENTAL MASSAGING PICKS (K850775)L.A.K. Ent., Inc.1985-04-10
ORAPIK PERIODONTAL SCALER (K844238)Dental Concepts, LLC1984-12-03
SANODENT DOUBLE-ENDED INTERDENTAL CLEAN (K832949)Coopercare, Inc.1983-10-04
FIXIDENT (K821629)Moyco Industries, Inc.1982-06-14
RESILIENT GUM EXERCISER (K820979)Martin A. Hass, D.D.S.1982-05-10

Track JET automatically

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