FDA-Device2025-03-19Class II
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A
TruAbutment Inc.
Hazard
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Sold states
US: CA, CO, FL, GA, IA, IL, MD, MN, MS, OH, OR, SD, UT, VA, WA, WI OUS: Japan, Great Britain , Canada
Affected count
61 units
Manufactured in
17666 Fitch, Irvine, CA, United States
Products
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2025Don't want to check this manually?
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