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FDAJune 25, 2021device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

straumann

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 Details · AllClear