510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JEWClass I

Tip, Rubber, Oral Hygiene

21 CFR 872.6650 / Dental
FDA source (opens on fda.gov)

JEW is the FDA product code for Tip, Rubber, Oral Hygiene, a class I device type, regulated under 21 CFR 872.6650. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JEW
Device name
Tip, Rubber, Oral Hygiene
Regulation
21 CFR 872.6650
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code JEW

By decision year
3 clearances under product code JEW with a decision year between 1979 and 1986, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JEW by decision year
YearClearances
19791
19841
19861

Applicants with the most clearances

Product code JEW
Applicants holding the most 510(k) clearances under product code JEW
ApplicantClearances
Arnell, Inc.1
Kallestad Laboratories, Inc.1
Senair-Mot1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order