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SureSmile®
ORAMETRIX, INC. · Model DIGI-500128 · UDI-DI 90856379007118
QJJ
Prescription
0
510(k) clearances
1
Adverse events
1
Recalls
38
Facilities
Description
Indirect Bonding (IDB) Tray
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-08 | Klowen Braces | A product error defect may cause incorrect bracket placement. |
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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.