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Gro3X DIU
Gro3x, Inc. · Model DIU-3D-71-001 · UDI-DI 00860006572501
NOF
Prescription
5
510(k) clearances
36
Adverse events
1
Recalls
148
Facilities
Description
Gro3X DIU system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Gro3X DIU system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-15 | CARESTREAM DENTAL, LLC | The mirror may become detached and fall from the unit |
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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.