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Devices
Device Recall Helioseal Clear
Model / Serial
REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020)
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.
Product Description
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
Manufacturer
Ivoclar Vivadent, Inc.
1 Event
Recall of Device Recall Helioseal Clear
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Manufacturer
Ivoclar Vivadent, Inc.
Manufacturer Address
Ivoclar Vivadent, Inc., 175 Pineview Dr, Buffalo NY 14228-2231
Manufacturer Parent Company (2017)
Ivoclar Vivadent Aktiengesellschaft
Source
USFDA
Language
English
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