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Avalon Biomed by Zarc SlimShaper PRO File one of each 31 mm (ZS1, ZS2, ZS3)
NUSMILE, LTD. · Model ZSS31APRO3 · UDI-DI 00810118104497
10
510(k) clearances
3,963
Adverse events
3
Recalls
168
Facilities
Description
Blister of 6 units + petals
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-02 | US Endodontics, LLC | Due to devices being irradiated above the established specification which my result in package integrity issues. |
| 2012-12-12 | Ormco/Sybronendo | The length markings on the Lightspeed LSX files were wrong. |
| 2008-08-01 | Ormco Corporation | A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.