FDA product code MZW: Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
MZW is the FDA product code for dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief. It is a Class II device, regulated under 21 CFR 872.3275 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under MZW, from 2 different applicants. The average 510(k) review took 82 days (median 82). FDA has posted 3 recalls for MZW devices.
Classification
| Field | Value |
|---|---|
| Device name | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief |
| Device class | Class II |
| Regulation | 21 CFR 872.3275 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MZW clearance
Top MZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kerr Corporation | 1 | 2008-01-29 |
| Closure Medical Corp. | 1 | 1999-09-02 |
Most recent MZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073209 | Kerr Corporation | MAXCEM 2 | 2008-01-29 | 76 |
| K991923 | Closure Medical Corp. | SOOTHE-N-SEAL CANKER SORE RELIEF | 1999-09-02 | 87 |
Recalls for MZW devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-09-23.
Frequently asked questions
What is FDA product code MZW?
MZW is the FDA product code for dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief. It is a Class II device, regulated under 21 CFR 872.3275 and reviewed by the Dental panel.
What device class is MZW?
Class II, regulation 21 CFR 872.3275. Typical premarket route: 510(k).
How long does a 510(k) take for product code MZW?
Across 2 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most MZW clearances?
Kerr Corporation (1); Closure Medical Corp. (1).
Have MZW devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2013-09-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MZW
- Run a recall and safety report across every MZW manufacturer
- Watch product code MZW 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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