Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

KeyPrint Soft- bottle Recalled by Straumann USA LLC Due to Product label intended for the European community was...

Date: June 25, 2021
Company: Straumann USA LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Straumann USA LLC directly.

Affected 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

Quantity: N/A

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Straumann USA LLC

Straumann USA LLC has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report