FDA product code KCQ: Tube Impression And Matrix
KCQ is the FDA product code for tube impression and matrix. It is a Class I device, regulated under 21 CFR 872.6570 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under KCQ. The average 510(k) review took 112 days (median 112).
Classification
| Field | Value |
|---|---|
| Device name | Tube Impression And Matrix |
| Device class | Class I |
| Regulation | 21 CFR 872.6570 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KCQ clearance
Top KCQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intl. Medical Marketing, Inc. | 1 | 1990-03-13 |
Most recent KCQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896621 | Intl. Medical Marketing, Inc. | L.T.C. REPLACEMENT GASTROSTOMY TUBE | 1990-03-13 | 112 |
Recalls for KCQ devices
openFDA lists no recalls for product code KCQ.
Frequently asked questions
What is FDA product code KCQ?
KCQ is the FDA product code for tube impression and matrix. It is a Class I device, regulated under 21 CFR 872.6570 and reviewed by the Dental panel.
What device class is KCQ?
Class I, regulation 21 CFR 872.6570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCQ?
Across 1 cleared submissions the average was 112 days from receipt to decision (median 112).
Which companies have the most KCQ clearances?
Intl. Medical Marketing, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KCQ
- Run a recall and safety report across every KCQ manufacturer
- Watch product code KCQ 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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