FDA-Device2021-12-15Class II
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Orchestrate Orthodontic Technologies, Inc.
Hazard
Due to product label/labeling being altered from it's approved state.
Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. The countries of Argentina, Australia, Bolivia, Brazil, Canada, Costa Rica, India, Ireland, Mongolia, New Zealand, Pakistan, Spain and Thailand.
Affected count
127 copies
Manufactured in
1747 N Riverside Ave, N/A, Rialto, CA, United States
Products
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0334-2022Don't want to check this manually?
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