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Real Arch
HDX WILL CORP. · Model Real Arch · UDI-DI 08800005200182
NOF
Prescription
5
510(k) clearances
36
Adverse events
1
Recalls
148
Facilities
Description
Real Arch is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues.The Real Arch is composed of a hand-piece, power hub, adapter and usb3.0 cable. The system produces 3D scans for use in computer- assisted design and manufacturing of dental restorations.
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.