FDA product code JET: Pick, Massaging
JET is the FDA product code for pick, massaging. It is a Class I device, regulated under 21 CFR 872.6650 and reviewed by the Dental panel. FDA has cleared 15 510(k) submissions under JET, from 15 different applicants. The average 510(k) review took 76 days (median 34). FDA has posted 2 recalls for JET devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pick, Massaging |
| 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 JET clearance
Top JET applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Whitehill Manufacturing, Inc. | 1 | 1996-12-16 |
| Oral-B Laboratories | 1 | 1995-04-27 |
| Arizona Implant Dentistry | 1 | 1993-07-28 |
| Burn-Henderson Partnership | 1 | 1991-07-17 |
| Dentek Corp. | 1 | 1989-03-17 |
10 more applicants have JET clearances. See the full list in Caduvo.
Most recent JET clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963747 | Whitehill Manufacturing, Inc. | REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. | 1996-12-16 | 90 |
| K942633 | Oral-B Laboratories | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE | 1995-04-27 | 328 |
| K930178 | Arizona Implant Dentistry | ELECTRO FLOSS | 1993-07-28 | 196 |
| K911418 | Burn-Henderson Partnership | GUM MASSAGER | 1991-07-17 | 107 |
| K885189 | Dentek Corp. | MASSAGING PICK FOR ORAL HYGIENE | 1989-03-17 | 91 |
Recalls for JET devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-12-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code JET?
JET is the FDA product code for pick, massaging. It is a Class I device, regulated under 21 CFR 872.6650 and reviewed by the Dental panel.
What device class is JET?
Class I, regulation 21 CFR 872.6650. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JET?
Across 15 cleared submissions the average was 76 days from receipt to decision (median 34).
Which companies have the most JET clearances?
Whitehill Manufacturing, Inc. (1); Oral-B Laboratories (1); Arizona Implant Dentistry (1); Burn-Henderson Partnership (1); Dentek Corp. (1).
Have JET devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code JET
- Run a recall and safety report across every JET manufacturer
- Watch product code JET 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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