FDA product code MMD: Toothbrush, Ionic, Battery-Powered
MMD is the FDA product code for toothbrush, ionic, battery-powered. It is a Class I device, regulated under 21 CFR 872.6865 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under MMD, from 2 different applicants. The average 510(k) review took 433 days (median 433). FDA has posted 5 recalls for MMD devices.
Classification
| Field | Value |
|---|---|
| Device name | Toothbrush, Ionic, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 872.6865 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MMD clearance
Top MMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sas Group, Inc. | 1 | 1997-06-24 |
| Hukuba Dental Corp. | 1 | 1994-03-04 |
Most recent MMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971639 | Sas Group, Inc. | PLUSTRON ION TOOTHBRUSH SYSTEM | 1997-06-24 | 53 |
| K915576 | Hukuba Dental Corp. | HUBUKA HYG TOOTHBRUSH | 1994-03-04 | 813 |
Recalls for MMD devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-03-23.
Frequently asked questions
What is FDA product code MMD?
MMD is the FDA product code for toothbrush, ionic, battery-powered. It is a Class I device, regulated under 21 CFR 872.6865 and reviewed by the Dental panel.
What device class is MMD?
Class I, regulation 21 CFR 872.6865. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MMD?
Across 2 cleared submissions the average was 433 days from receipt to decision (median 433).
Which companies have the most MMD clearances?
Sas Group, Inc. (1); Hukuba Dental Corp. (1).
Have MMD devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2012-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MMD
- Run a recall and safety report across every MMD manufacturer
- Watch product code MMD 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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