FDA product code KXR: Applicator, Resin
KXR is the FDA product code for applicator, resin. It is a Class I device, regulated under 21 CFR 872.3140 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under KXR, from 3 different applicants. The average 510(k) review took 51 days (median 57).
Classification
| Field | Value |
|---|---|
| Device name | Applicator, Resin |
| Device class | Class I |
| Regulation | 21 CFR 872.3140 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KXR clearance
Top KXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centrix, Inc. | 1 | 1983-10-04 |
| 3M Company | 1 | 1978-09-29 |
| Deringer-Ney, Inc. | 1 | 1977-01-31 |
Most recent KXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832662 | Centrix, Inc. | DENTAL SYRINGE SYSTEM-VARIOUS STYLES | 1983-10-04 | 57 |
| K781098 | 3M Company | BRUSH, APPLICATOR | 1978-09-29 | 88 |
| K770160 | Deringer-Ney, Inc. | CERAMIST BRUSH | 1977-01-31 | 7 |
Recalls for KXR devices
openFDA lists no recalls for product code KXR.
Frequently asked questions
What is FDA product code KXR?
KXR is the FDA product code for applicator, resin. It is a Class I device, regulated under 21 CFR 872.3140 and reviewed by the Dental panel.
What device class is KXR?
Class I, regulation 21 CFR 872.3140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KXR?
Across 3 cleared submissions the average was 51 days from receipt to decision (median 57).
Which companies have the most KXR clearances?
Centrix, Inc. (1); 3M Company (1); Deringer-Ney, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KXR
- Run a recall and safety report across every KXR manufacturer
- Watch product code KXR 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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