Dharma Cavity Varnish Recalled for Missing FDA Clearance
Dharma Research, Inc. is recalling Dharma Cavity Varnish 15mL because the product was marketed without a cleared 510(k) submission.
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, but the source text identifies the issue as a regulatory compliance failure (missing 510(k)) rather than a physical defect or reported injury. Per the rubric, this aligns with moderate severity for regulatory or labeling issues without reported harm.
Plain-English summary
Dharma Research, Inc. is recalling 916 units of Dharma Cavity Varnish 15mL. The recall was initiated after an FDA inspection revealed that the products were marketed without a cleared 510(k) submission, which is required for medical devices.
The affected product is identified by Item # 14-00016 and includes all lots. The distribution pattern includes the United States (specifically California, Pennsylvania, Florida, Illinois, and Puerto Rico) and international locations including Honduras, the Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, the Philippines, Saudi Arabia, and the United Arab Emirates.
Consumers and healthcare providers should stop using the product and contact Dharma Research, Inc. for further instructions or a refund.
The recalled product
- Product
- Dharma Cavity Varnish 15mL
- Manufacturer
- Dharma Research, Inc.
- Category
- Medical Device — Dental
- Affected units
- 916
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 # 14-00016
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 Lack of FDA Clearance
FDA (Devices) · 2014-12-03
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