Device product
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Z-0564-2016
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 72658
- Status
- Terminated
- Classification
- Class II
- Quantity
- 686
- Official record key
device-enforcement:Z-0564-2016
Official wording
Reason: Images contained within radiographic transparency ART 1036 are undersized.
Code information: Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.
Distribution pattern: Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.
Derived failure modes
-
Unknown
Images contained within radiographic transparency ART 1036 are undersized.