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U.S. Department of Health and Human Services

Class 2 Device Recall Bluephase Style Light Pin Point Probe 62 mm

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 Class 2 Recall
Bluephase Style Light Pin Point Probe 62 mm
see related information
Date Posted June 09, 2014
Recall Status1 Open
Recall Number Z-1740-2014
Recall Event ID 67998
Premarket Notification
510(K) Number
K110756 
Product Classification Activator, Ultraviolet, For Polymerization - Product Code EBZ
Product "bluephase style Light probe Pin-point 6>2 mm black***REF # 636 241". Ultraviolet activator for polymerization for use during dental curing.
Code Information Reference number 636241, all lots
Recalling Firm/
Manufacturer
Ivoclar Vivadent, Inc.
175 Pineview Dr
Buffalo, New York 14228-2231
Manufacturer Reason
for Recall
Subject of this recall is an accessory to a dental curing light called Bluephase Style. The accessory is a pin point light probe. A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
Action lvoclar Vivadent, Inc. sells the affected medical device through Dental Dealer partners (initial consignees) who in turn sell directly to the dentist's office. In this case, lvoclar Vivadent, Inc. handled direct drop shipment of the device to end user dental offices in 80% of the cases. Where lvoclar Vivadent has direct shipment information available, dentist offices will be notified directly. The Dental Dealer partners will be notified of this recall and asked to cooperate and provide name and address listings for all dental office customers where they have shipped the Pin Point probe. The dealer will also be given a customer communication to send directly to the dentists purchasing the device.
Quantity in Commerce 241 units
Distribution Nationwide Distribution and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = EBZ and Original Applicant = IVOCLAR VIVADENT, INC.
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