FDA Device Intelligence
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Planmeca Emerald S

D4D TECHNOLOGIES, LLC · Model 15600005 - Emerald S Scanner Kit, OY · UDI-DI 00858809006200

NOF Prescription
5
510(k) clearances
36
Adverse events
1
Recalls
148
Facilities

Description

Qty 1 - 1560004 - Emerald S Scanner (US) Qty 1 - 15600105 - Emerald S Scanner Accessories (Includes 1 Scanner Cable, 1 Color Balancer, 3 Tips)

Recalls

DateFirmReason
2021-02-15CARESTREAM DENTAL, LLCThe mirror may become detached and fall from the unit

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Data 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.