FDA product code NYH: Plaque Disclosing Kit
NYH is the FDA product code for plaque disclosing kit. It is a Class II device, regulated under 21 CFR 872.1740 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under NYH. The average 510(k) review took 21 days (median 21).
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Plaque Disclosing Kit |
| Device class | Class II |
| Regulation | 21 CFR 872.1740 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NYH clearance
Top NYH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clairol, Inc. | 1 | 1978-12-04 |
Most recent NYH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781919 | Clairol, Inc. | PLAQUE DETECTION SYSTEM | 1978-12-04 | 21 |
Recalls for NYH devices
openFDA lists no recalls for product code NYH.
Frequently asked questions
What is FDA product code NYH?
NYH is the FDA product code for plaque disclosing kit. It is a Class II device, regulated under 21 CFR 872.1740 and reviewed by the Dental panel.
What device class is NYH?
Class II, regulation 21 CFR 872.1740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NYH?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most NYH clearances?
Clairol, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NYH
- Run a recall and safety report across every NYH manufacturer
- Watch product code NYH 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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