FDA product code JEW: Tip, Rubber, Oral Hygiene
JEW is the FDA product code for tip, rubber, oral hygiene. It is a Class I device, regulated under 21 CFR 872.6650 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under JEW, from 3 different applicants. The average 510(k) review took 76 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | Tip, Rubber, Oral Hygiene |
| Device class | Class I |
| Regulation | 21 CFR 872.6650 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JEW clearance
Top JEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arnell, Inc. | 1 | 1986-09-25 |
| Senair-Mot | 1 | 1984-12-11 |
| Kallestad Laboratories, Inc. | 1 | 1979-05-15 |
Most recent JEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K862635 | Arnell, Inc. | RABINOWITZ GUM MASSAGER | 1986-09-25 | 77 |
| K843406 | Senair-Mot | CHEW-DENT | 1984-12-11 | 102 |
| K790588 | Kallestad Laboratories, Inc. | ASSAY REAGENTS, LSA 290 | 1979-05-15 | 49 |
Recalls for JEW devices
openFDA lists no recalls for product code JEW.
Frequently asked questions
What is FDA product code JEW?
JEW is the FDA product code for tip, rubber, oral hygiene. It is a Class I device, regulated under 21 CFR 872.6650 and reviewed by the Dental panel.
What device class is JEW?
Class I, regulation 21 CFR 872.6650. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JEW?
Across 3 cleared submissions the average was 76 days from receipt to decision (median 77).
Which companies have the most JEW clearances?
Arnell, Inc. (1); Senair-Mot (1); Kallestad Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JEW
- Run a recall and safety report across every JEW manufacturer
- Watch product code JEW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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