FDA product code MAU: Eraser, Dental Stain
MAU is the FDA product code for eraser, dental stain. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under MAU, from 2 different applicants. The average 510(k) review took 176 days (median 176). FDA has posted 1 recall for MAU devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Eraser, Dental Stain |
| Device class | Class I |
| Regulation | 21 CFR 872.6855 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every MAU clearance
Top MAU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Precident Group | 1 | 2000-05-03 |
| The Smylon Co. | 1 | 1989-11-14 |
Most recent MAU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000140 | The Precident Group | CLINI-DENT | 2000-05-03 | 106 |
| K891338 | The Smylon Co. | SMYLON (DENTAL STAIN ERASER) | 1989-11-14 | 246 |
Recalls for MAU devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-04.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code MAU?
MAU is the FDA product code for eraser, dental stain. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel.
What device class is MAU?
Class I, regulation 21 CFR 872.6855. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MAU?
Across 2 cleared submissions the average was 176 days from receipt to decision (median 176).
Which companies have the most MAU clearances?
The Precident Group (1); The Smylon Co. (1).
Have MAU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code MAU
- Run a recall and safety report across every MAU manufacturer
- Watch product code MAU 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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