Recall Z-2336-2021— Straumann USA LLC
Class II · Ongoing
Class II FDA medical device recall by Straumann USA LLC, initiated 2021-06-25. It names one FDA 510(k) clearance: K183598. 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. Reason: Product label intended for the European community was distributed to the USA market via their US distribution organization.
- Recalling firm
- Straumann USA LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-06-25
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Product label intended for the European community was distributed to the USA market via their US distribution organization
Data sourced from openFDA. This site is unofficial and independent of the FDA.