Class II — Bien Air Dental SA
| Recalling firm | BIEN-AIR DENTAL SA |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Possible loosening of the dental tool, which may lead to potential swallowing of the tool. |
| Product | Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures |
| Quantity | 112 (U.S.) |
| Distribution | Worldwide Distribution - US distribution to one distributor in FL. |
| Initiated | 2015-08-27 |
| Classified | 2015-09-21 |
| Terminated | 2016-03-31 |
| Recall number | Z-2797-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bien Air Dental SA (Z-2797-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72079/
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