FDA-Device2015-04-29Class II
M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
Specialty Appliance Works, Inc.
Hazard
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Sold states
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Affected count
14,428 Universal Nuts
Manufactured in
4905 Hammond Industrial Dr, Cumming, GA, United States
Products
M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1506-2015Don't want to check this manually?
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