StarDental Classique Diamond Dental Bur Recall for Coating Adhesion Issues
Dental EZ Stardental Division is recalling 3,560 StarDental Classique Diamond Dental Burs because a manufacturing issue prevented the diamond coating from adhering properly to the shank.
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, and the source text describes a manufacturing defect (coating adhesion) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Dental EZ Stardental Division is recalling 3,560 units of StarDental Classique(TM) Diamond Dental Burs. These products are used for specific applications in dental procedures. The recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for the affected lots.
The affected products were distributed worldwide, including nationwide in the United States (specifically in CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI) and in Japan. The recall covers specific item numbers and lot numbers, including Item 200169, Item 200174, and others as detailed in the agency's structured data.
Dental EZ Stardental Division is the recalling firm. Consumers and healthcare providers should stop using the affected dental burs and contact the manufacturer for further instructions or a refund.
The recalled product
- Product
- StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
- Manufacturer
- Dental EZ Stardental Division
- Hazard
- Affected units
- 3,560
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 (20)
- Item 200169
- lot numbers 2140459 and 2177284
- Item 200174
- lot numbers 2151776 and 2158861
- Item 200276
- lot number 2149190
- Item 200288
- lot number 2143968
- Item 200329
- lot number 2139572
- Item 200339
- lot number 2159105
- Item 200354
- lot number 2149191
- Item 200394
- lot number 2164110
- Item 200402
- lot numbers 2143162 and 2156621
- Item 200415
- lot number 2139573
Distribution
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