FDA-Device2015-09-30Class II

Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

Bien Air Dental SA
Hazard

Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

Sold states
Worldwide Distribution - US distribution to one distributor in FL.
Affected count
112 (U.S.)
Manufactured in
Langgasse 60, N/A, Biel/bienne, N/A, Switzerland
Products
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2797-2015

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