Written and maintained by CASRAI Editorial Board
Last updated
General product information only. This page is not medical or dental advice; follow the product label and your dentist’s instructions.
Short answer
Plaque disclosing tablets are chewable tablets that temporarily stain dental plaque so it can be seen on tooth surfaces. FDA lists the product category as “plaque disclosing agent” (product code QJC), a Class 1 dental device that is 510(k) exempt and supplied as a water-soluble tablet or gel.
Definition and scope
FDA’s product classification database names the device “plaque disclosing agent” and defines it as intended “to enhance visualization of the presence of plaque on tooth surfaces.” It records the technical method as temporary staining of plaque and the physical state as a water-soluble tablet or gel (FDA Product Classification, code QJC, checked 2026-10-30). A disclosing tablet is therefore the tablet form of this one category, not a separate class of product.
A disclosing agent does not remove plaque; per the FDA record it temporarily stains it so that it can be seen on tooth surfaces (FDA Product Classification, code QJC, checked 2026-10-30).
What the manufacturer’s label covers
The instructions for use (IFU) of one professional-use product, ORADOX REVEAL from Prevest DenPro, describe the tablets as chewable and “used to stain dental plaque and make it visible to naked eye.” Its IFU names two intended settings, improving a person’s own brushing and supporting professional oral prophylaxis, and sets out the directions for each. Those directions belong to the product label, which is the authority on how the product is used; this page does not substitute for it (Prevest DenPro IFU, checked 2026-10-30).
The same IFU states that the tablets are not to be swallowed, that the colouring is strong and can stain clothing, and that a known allergy to any ingredient is a contraindication.
Tablet, gel and related forms
| Form | What the source states |
|---|---|
| Tablet | Water-soluble tablet; chewed so that it stains plaque temporarily (FDA code QJC; Prevest DenPro IFU) |
| Gel | Listed by FDA as the other physical state for the same category (FDA code QJC) |
Source: FDA Product Classification, code QJC, and the Prevest DenPro IFU, both checked 2026-10-30. Both forms fall under the same classification record, so the regulatory category does not change between them.
What to read on an IFU before a supply decision
The FDA record tells a clinic or lab how the category is regulated. The product’s own IFU supplies the details that differ between products. Using the ORADOX REVEAL IFU as the worked example, these are the points it states, which can be compared line by line against any other disclosing tablet:
| Check | What the example IFU states |
|---|---|
| Composition | Xylitol, PVP, citric acid, sodium benzoate, excipients, colouring and flavouring agent |
| Contraindication | Known allergy to any ingredient |
| Precautions | Tablets are not to be swallowed; strong colouring can stain clothing |
| Storage | 10 to 24 °C (50 to 75 °F), kept dry and away from heat |
| Shelf life | 2 years unopened |
| Presentation | Packs of 30 or 60 tablets; non-sterile |
| Intended user | Developed solely for professional dental use |
Source: Prevest DenPro, ORADOX REVEAL instructions for use, checked 2026-10-30. Other products may state different values, so each product’s own IFU is the document to compare.
Common misunderstandings
“A disclosing tablet cleans the teeth”
It does not. FDA describes the method as temporary staining of plaque, and the IFU describes the tablet as a stain that makes plaque visible. Removing plaque is a separate matter from showing where it is.
“Class 1 means the tablets are proven to improve oral health”
Class 1 is a regulatory classification. It describes the level of FDA control and the 510(k) exemption; it is not a statement about clinical outcomes.
“All disclosing products are the same”
FDA groups them in one category, but the ingredients, storage range, shelf life and intended user are set by each product’s IFU, as the table above shows for one example.
Frequently asked questions
What are plaque disclosing tablets?
Chewable tablets that temporarily stain dental plaque so it can be seen. FDA classifies the category as plaque disclosing agent, product code QJC.
Are plaque disclosing tablets regulated as medical devices?
Yes. FDA’s classification database lists the plaque disclosing agent as a Class 1 dental device, 510(k) exempt, in tablet or gel form.
Do disclosing tablets remove plaque?
No. FDA describes the method as temporary staining of plaque, which makes it visible; staining is not removal.
What does an IFU list for a disclosing tablet?
The example IFU lists composition, contraindication, precautions, storage conditions, shelf life, presentation and intended user, as the table above shows. Another product’s IFU may state different values.
Related CASRAI guides
Related oral-care products are covered in the guides to the manual toothbrush, interdental brushes and dental floss types. Another tablet-format oral-care product, regulated differently, is covered in denture cleaning tablets.
Sources
- FDA, Product Classification, product code QJC, plaque disclosing agent: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=QJC, checked 2026-10-30.
- Prevest DenPro, ORADOX REVEAL instructions for use: https://www.prevestdenpro.com/wp-content/uploads/2026/04/ORADOX-REVEAL-IFU.pdf, checked 2026-10-30.
