FDA-Device2014-06-18Class II

bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.

Ivoclar Vivadent, Inc.
Hazard

A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.

Sold states
Worldwide Distribution: US Nationwide and the country of Canada.
Affected count
241 units
Manufactured in
175 Pineview Dr, N/A, Buffalo, NY, United States
Products
bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1740-2014

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