3M Removes Crown Indication from Lava Ultimate Dental Blocks
3M is initiating a field correction to remove the crown indication from all Lava Ultimate products. The products remain indicated for onlays, inlays, and veneers.
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 a field correction to remove a product indication rather than a safety recall for a specific defect or hazard. The source text does not report any injuries, illnesses, or deaths, and the hazard is theoretical or administrative in nature, fitting the criteria for a moderate severity voluntary precautionary action.
Plain-English summary
3M Company - Health Care Business is initiating a field correction to remove the crown indication from all products in the Lava Ultimate product family. These products are dental blocks used by dental offices for chairside milling and by dental laboratories for implant crown restoratives. The correction applies to all products in the Lava Ultimate product family, including various block versions compatible with Sirona, E4D, Straumann, TS150, Carestream, Roland, Planmill, and Ceramill mills, as well as frame/blank versions used by dental laboratories.
The field correction is being initiated to remove the crown indication from these products. Following this correction, the products will continue to be indicated for onlays, inlays, and veneers. The source text does not specify a particular hazard, injury, or illness associated with the use of these products for crowns, nor does it provide specific lot numbers or dates for the affected units.
The affected products were distributed worldwide, including nationwide in the United States and in numerous countries across Asia, Europe, the Americas, and Africa. The total quantity affected is 1.8 million units, with 1,017,834 units in the US. Consumers and dental professionals should refer to the specific field correction notice for instructions on how to proceed with the removal of the crown indication.
The recalled product
- Product
- Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill…
- Manufacturer
- 3M Company - Health Care Business
- Hazard
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 (1)
- All products in the Lava Ultimate product family.
Distribution
Distributed nationwide across the United States.
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