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LuxCreo Clear Aligner System
Luxcreo Inc · Model DCA-TB · UDI-DI 00860010425404
1
510(k) clearances
18,531
Adverse events (1 deaths)
2
Recalls
99
Facilities
Description
Product Name:LuxCreo Clear Aligner System;Model Numbers:DCA-TB;Color:colorless and transparent.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-22 | 3M Company - Health Care Business | Attachments may not mate with the tooth as intended in the digital treatment design. |
| 2024-11-04 | Straight Smile, LLC | Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindicatio |
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