CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
Premier Solo Diamond - Large Invented Cone recalled
Premier Dental Products is recalling Premier Solo Diamond - Large Invented Cone, distributed nationwide in the US. The recall was initiated on 27 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1408-2025
- FDA event ID
- 96394
- Recalling firm
- Premier Dental Products, Plymouth Meeting, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2025
- FDA classified
- 21 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Feb 2025 | Recall initiated by company | |
| 21 Mar 2025 | Classified by FDA | +22 days |
| 2 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The hardness not meeting the material specification and may cause the diamond bur to bend.
Product as listed by the FDA
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Where it was distributed
US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
Nationwide CaliforniaMinnesotaNew YorkPennsylvaniaTennesseeVirginiaWashington
Questions about this recall
Why was it recalled?
The hardness not meeting the material specification and may cause the diamond bur to bend.
Which lots are affected?
SKU: 807016C; UDI-DI: 00348783000237; Lot Numbers: M0117646, M0120260, M0123294;
Where was it sold?
US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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