FDA product code KOP: Adhesive, Denture, Karaya
KOP is the FDA product code for adhesive, denture, karaya. It is a Class I device, regulated under 21 CFR 872.3450 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under KOP. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Karaya |
| Device class | Class I |
| Regulation | 21 CFR 872.3450 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KOP clearance
Top KOP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ohio Medical Products | 1 | 1980-10-03 |
Most recent KOP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802285 | Ohio Medical Products | OHIO THORACIC SUCTION REGULATOR | 1980-10-03 | 14 |
Recalls for KOP devices
openFDA lists no recalls for product code KOP.
Frequently asked questions
What is FDA product code KOP?
KOP is the FDA product code for adhesive, denture, karaya. It is a Class I device, regulated under 21 CFR 872.3450 and reviewed by the Dental panel.
What device class is KOP?
Class I, regulation 21 CFR 872.3450. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOP?
Across 1 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most KOP clearances?
Ohio Medical Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KOP
- Run a recall and safety report across every KOP manufacturer
- Watch product code KOP 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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