SleeperOne 5

DENTALHITEC · Model SO_5C · UDI-DI 03760349803331

EJI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1 SleeperOne 5 handpiece and control box 1 wireless pedal 1 battery charger 1 power supply, 10 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521)

Recalls

Date	Firm	Reason
2015-02-11	Milestone Scientific, Inc.	Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.

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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.