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Recall

Class II — Premier Dental Products Co

Recalling firmPremier Dental Products Company
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonThe hardness not meeting the material specification and may cause the diamond bur to bend.
ProductPremier Solo Diamond - Large Invented Cone; SKU: 807016C.
Quantity77 units
DistributionUS Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
Initiated2025-02-27
Classified2025-03-21
Recall numberZ-1408-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Premier Dental Products Co (Z-1408-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96394/

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