Recall Z-1408-2025— Premier Dental Products Co
Class II · Ongoing
Class II FDA medical device recall by Premier Dental Products Co, initiated 2025-02-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Premier Solo Diamond - Large Invented Cone; SKU: 807016C.. Reason: The hardness not meeting the material specification and may cause the diamond bur to bend..
- Recalling firm
- Premier Dental Products Co
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-27
- Firm location
- Plymouth Meeting, PA, United States
Product description
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Reason for recall
The hardness not meeting the material specification and may cause the diamond bur to bend.
Data sourced from openFDA. This site is unofficial and independent of the FDA.