FDA product code KZP: Solution, Cement Dissolving
KZP is the FDA product code for solution, cement dissolving. It is a Class II device, regulated under 21 CFR 872.3750 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under KZP, from 2 different applicants. The average 510(k) review took 248 days (median 248). FDA has posted 1 recall for KZP devices.
Classification
| Field | Value |
|---|---|
| Device name | Solution, Cement Dissolving |
| Device class | Class II |
| Regulation | 21 CFR 872.3750 |
| 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 KZP clearance
Top KZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Confi-Dental Products Co. | 1 | 1993-04-08 |
| Den-Mat Corp. | 1 | 1978-01-12 |
Most recent KZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920843 | Confi-Dental Products Co. | TOOTH CONDITIONER | 1993-04-08 | 408 |
| K771974 | Den-Mat Corp. | SOLVENEX I-0 | 1978-01-12 | 87 |
Recalls for KZP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-02-10.
Frequently asked questions
What is FDA product code KZP?
KZP is the FDA product code for solution, cement dissolving. It is a Class II device, regulated under 21 CFR 872.3750 and reviewed by the Dental panel.
What device class is KZP?
Class II, regulation 21 CFR 872.3750. Typical premarket route: 510(k).
How long does a 510(k) take for product code KZP?
Across 2 cleared submissions the average was 248 days from receipt to decision (median 248).
Which companies have the most KZP clearances?
Confi-Dental Products Co. (1); Den-Mat Corp. (1).
Have KZP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-02-10.
Next steps
- Run an FDA pathway report with predicate devices for product code KZP
- Run a recall and safety report across every KZP manufacturer
- Watch product code KZP 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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