FDA product code JER: Cleaner, Denture, Mechanical
JER is the FDA product code for cleaner, denture, mechanical. It is a Class I device, regulated under 21 CFR 872.3530 and reviewed by the Dental panel. FDA has cleared 14 510(k) submissions under JER, from 13 different applicants. The average 510(k) review took 57 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Cleaner, Denture, Mechanical |
| Device class | Class I |
| Regulation | 21 CFR 872.3530 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JER clearance
Top JER applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Great Lakes Orthodontics, Ltd. | 2 | 1984-03-30 |
| Connoisseurs Products Corp. | 1 | 1988-10-25 |
| Tatung Company of America, Inc. | 1 | 1988-08-26 |
| Dental Research Laboratories | 1 | 1987-08-11 |
| Astron Dental Corp. | 1 | 1985-07-31 |
8 more applicants have JER clearances. See the full list in Caduvo.
Most recent JER clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883403 | Connoisseurs Products Corp. | DENTA PLUS | 1988-10-25 | 75 |
| K881391 | Tatung Company of America, Inc. | ULTRASONIC DENTURE CLEANER | 1988-08-26 | 144 |
| K872521 | Dental Research Laboratories | DENTURE CLEANSERS | 1987-08-11 | 47 |
| K852906 | Astron Dental Corp. | DURACLEAN DENTURE CLEANER | 1985-07-31 | 22 |
| K840805 | Great Lakes Orthodontics, Ltd. | ORAL SAFE | 1984-03-30 | 35 |
Recalls for JER devices
openFDA lists no recalls for product code JER.
Frequently asked questions
What is FDA product code JER?
JER is the FDA product code for cleaner, denture, mechanical. It is a Class I device, regulated under 21 CFR 872.3530 and reviewed by the Dental panel.
What device class is JER?
Class I, regulation 21 CFR 872.3530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JER?
Across 14 cleared submissions the average was 57 days from receipt to decision (median 50).
Which companies have the most JER clearances?
Great Lakes Orthodontics, Ltd. (2); Connoisseurs Products Corp. (1); Tatung Company of America, Inc. (1); Dental Research Laboratories (1); Astron Dental Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JER
- Run a recall and safety report across every JER manufacturer
- Watch product code JER 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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