FDA-Device2024-01-10Class II
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Keystone Industries
Hazard
Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).
Sold states
Worldwide distribution - US Nationwide and the country of China.
Affected count
336 units
Manufactured in
480 S Democrat Rd, N/A, Gibbstown, NJ, United States
Products
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0630-2024Don't want to check this manually?
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