FDA product code MCF: Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
MCF is the FDA product code for unit, ultraviolet sanitation/sterilization (for toothbrushes), sterile. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under MCF, from 5 different applicants. The average 510(k) review took 158 days (median 181). FDA has posted 1 recall for MCF devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile |
| Device class | Class I |
| Regulation | 21 CFR 872.6855 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MCF clearance
Top MCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hwadong International Company , Ltd. | 1 | 2003-05-28 |
| Germ Terminator Corporation | 1 | 2002-05-10 |
| Otres, LLC | 1 | 2001-06-06 |
| Associated Mills, Inc. | 1 | 1990-09-17 |
| Purebrush Assoc. | 1 | 1990-05-15 |
Most recent MCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023662 | Hwadong International Company , Ltd. | PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER | 2003-05-28 | 209 |
| K021258 | Germ Terminator Corporation | GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER | 2002-05-10 | 21 |
| K003517 | Otres, LLC | OTRES TOOTHBRUSH SANITIZER MODEL TB100W | 2001-06-06 | 204 |
| K901459 | Associated Mills, Inc. | DS60 TOOTHBRUSH SANITIZER | 1990-09-17 | 173 |
| K896481 | Purebrush Assoc. | PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER | 1990-05-15 | 181 |
Recalls for MCF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-04-05.
Frequently asked questions
What is FDA product code MCF?
MCF is the FDA product code for unit, ultraviolet sanitation/sterilization (for toothbrushes), sterile. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel.
What device class is MCF?
Class I, regulation 21 CFR 872.6855. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MCF?
Across 5 cleared submissions the average was 158 days from receipt to decision (median 181).
Which companies have the most MCF clearances?
Hwadong International Company , Ltd. (1); Germ Terminator Corporation (1); Otres, LLC (1); Associated Mills, Inc. (1); Purebrush Assoc. (1).
Have MCF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-04-05.
Next steps
- Run an FDA pathway report with predicate devices for product code MCF
- Run a recall and safety report across every MCF manufacturer
- Watch product code MCF 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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