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Circle One
CIRCLE ANATOSCOPE INTUITIVE DESIGN · Model V.1.X.X · UDI-DI 03760434300004
5
510(k) clearances
36
Adverse events
1
Recalls
148
Facilities
Description
Circle ONE Design is a software device intended to support the design of the following dental prostheses: full crowns, partial crowns (onlay, inlay, overlay), veneers. It allows the import of 3D intraoral scan data and provides automated prosthetic design proposals that can be reviewed, adjusted and exported for manufacturing.
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.