Straumann USA LLC KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
Brand
Straumann USA LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U
Straumann USA LLC is recalling KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances due to Product label intended for the European community was distributed to the USA market via their US distribution organization. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product label intended for the European community was distributed to the USA market via their US distribution organization
Recommended Action
Per FDA guidance
Straumann USA initial notification to the customer via phone call on 25 June 2021. A follow-up letter dated 7/2/21 issued. Letter states reason for recall, health risk and action to take: Action to be taken: 1. Based on our conversation on 25 June 2021, you did not use and you have segregated the product and it was made ready to ship back to us. 2. Complete and return the enclosed Customer Confirmation Form to FSCA ER21-0118, Straumann USA, LLC; 60 Minuteman Road, Andover, MA 01810 along with the product using the attached label.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026