FDA product code KCR: Facebow
KCR is the FDA product code for facebow. It is a Class I device, regulated under 21 CFR 872.3220 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under KCR. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Facebow |
| Device class | Class I |
| Regulation | 21 CFR 872.3220 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KCR clearance
Top KCR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Almore Intl., Inc. | 1 | 1983-04-28 |
Most recent KCR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830775 | Almore Intl., Inc. | FACEBOW FOR BALANCE ARTICULATOR | 1983-04-28 | 48 |
Recalls for KCR devices
openFDA lists no recalls for product code KCR.
Frequently asked questions
What is FDA product code KCR?
KCR is the FDA product code for facebow. It is a Class I device, regulated under 21 CFR 872.3220 and reviewed by the Dental panel.
What device class is KCR?
Class I, regulation 21 CFR 872.3220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCR?
Across 1 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most KCR clearances?
Almore Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KCR
- Run a recall and safety report across every KCR manufacturer
- Watch product code KCR 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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