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ACTEON

SATELEC · Model HANDPIECE MINILED AF2 OEM · UDI-DI 03609820053028

EBZ Prescription

510(k) clearances

171

Adverse events

Recalls

103

Facilities

Description

The AutoFocus by Acteon The power density (number of photons) of a lamp decreases significantly the farther away it is from the composite. To ensure effective polymerization, the exposure time would need to be calculated for each clinical procedure, according the position of the tooth, and even the shape of the composite. The AutoFocus function is an “active” system which enables automatic calculation of the time, and therefore of the ideal power density, required for deep polymerization of composites, whatever menu is selected. This will avoid under or overexposure of time and stop any inflammation..

Recalls

Date	Firm	Reason
2022-01-20	Envisiontec US Llc	The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
2018-04-04	Handpiece Headquarters	Tip of the curing light was too hot causing a heat sensation in the patients.
2014-04-14	Ivoclar Vivadent, Inc.	A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
2012-04-23	O'Ryan Industries Inc	Disposa-Shield Disposable Curing Shield is recalled due to lacking 510K, PMA or IDE, and inadequate quality system.

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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.