FDA-Device2021-09-01Class II

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

Straumann USA LLC
Hazard

Product label intended for the European community was distributed to the USA market via their US distribution organization

Sold states
US Nationwide distribution in the state of TX.
Affected count
N/A
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2336-2021

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