FDA-Device2017-10-04Class II
Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Ultradent Products, Inc.
Hazard
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Sold states
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
Affected count
61 units
Manufactured in
505 W 10200 S, N/A, South Jordan, UT, United States
Products
Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3214-2017Don't want to check this manually?
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