Dharma Cavity Varnish Recalled for Lack of FDA Clearance
Dharma Research, Inc. is recalling Dharma Cavity Varnish with Fluoride because the product was marketed without a cleared 510(k).
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a moderate risk. The hazard is a regulatory compliance issue (lack of 510(k) clearance) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity score.
Plain-English summary
Dharma Research, Inc. is recalling Dharma Cavity Varnish with Fluoride, Item #14-00015. The recall involves 2,842 units distributed worldwide, including in the United States (CA, PA, FL, IL, and Puerto Rico) and various international locations.
The recall was initiated after an FDA inspection revealed that the products were being marketed without a cleared 510(k). This regulatory deficiency means the device has not received the necessary FDA clearance for its intended use.
Consumers and healthcare providers should stop using the product and contact Dharma Research, Inc. for further instructions.
The recalled product
- Product
- Dharma Cavity Varnish with Fluoride
- Manufacturer
- Dharma Research, Inc.
- Category
- Medical Device — Dental
- Affected units
- 2,842
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots - Item #14-00015
Distribution
Part of a larger recall action
This product is one of 2 recalled by Dharma Research, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Dharma Research, Inc.
See all →- ModerateDharma Cavity Varnish Recalled for Missing FDA Clearance
FDA (Devices) · 2014-12-03
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateLumiQuick Methadone Test Cards Recalled for Lack of FDA Clearance
FDA (Devices) · 2014-04-16
- ModerateLumiQuick Methamphetamine Strip Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
- HighCIRCUL8 LUXE DVT Prevention Device Marketed Without FDA Clearance
FDA (Devices) · 2021-08-25
- ModerateLumiQuick Recalls Tramadol Strips Shipped Without FDA Clearance
FDA (Devices) · 2014-04-16
- ModerateLumiQuick Methylphenidate Test Card Recalled for Unapproved Distribution
FDA (Devices) · 2014-04-16
- ModerateClark Laboratories Recalls Genesys Diluent Reagent for Lack of 510(k) Clearance
FDA (Devices) · 2018-12-26