Plaque Disclosing Kit
The Plaque Disclosing Kit (product code NYH) is a Class 2 dental convenience kit containing plaque-disclosing agents and related accessories used to visually identify dental plaque on tooth surfaces, regulated under 21 CFR 872.1740 within the Dental specialty. As a convenience kit under the May 1997 Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) if all guidance criteria are met. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NYH
- Device Class
- FDA class 2
- Regulation Number
- 872.1740
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 7
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K781919 | PLAQUE DETECTION SYSTEM | Dec 04, 1978 | Substantially Equivalent | Clairol, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.