Premier Dental Products Co recalls Premier Solo Diamond - Large Invented Cone

The hardness not meeting the material specification and may cause the diamond bur to bend.

Premier Solo Diamond - Large Invented Cone; SKU: 807016C.

On February 25, 2025 MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Immediately examine your inventory and quarantine all product subject to this recall, including individual bottles in partial boxes. This recall should be carried out to the healthcare practitioner level. If you have further distributed this product, please identify and notify all your customers that received the affected SKU and lot numbers of this product at once. You may include a copy of this notification with your communication to your customers that have received affected product. Please have your customers account for all product in their possession and arrange for the return of all affected product. Your customers should return the affected product to you for consolidation first prior to returning to Premier Dental Products Company. Please complete the enclosed Required Recall Notice Response form and return to Premier immediately via email (regulatory@premierdentalco.com) or mail with the returned product to: Premier Solo Diamond Attn: Jessica Huang Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, PA 19462 Upon receipt of the returned product at Premier Dental, Premier s Customer Experience can issue a credit or Premier can replace the returned item with SKU 807018C - SOLO Diamond Large Inverted Cone. If you have any further questions regarding billing or replacements, please contact Customer Experience at info@premierdentalco.com. We thank you for your assistance in completing this activity and apologize for any inconvenience that this may cause.

• FDA enforcement recordOfficial FDA database entry for Z-1408-2025
• FDA device classification · EJLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3240The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Premier Dental Products CoSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.