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Helioseal/Clear/F/F Plus
IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Model 686772AN · UDI-DI 07615208294187
EBC
Prescription
10
510(k) clearances
57
Adverse events
3
Recalls
88
Facilities
Description
Helioseal F Plus Refill 1x1g
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-17 | Ultradent Products, Inc. | There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode |
| 2016-02-12 | Ivoclar Vivadent, Inc. | Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the pro |
| 2015-10-07 | Ivoclar A. G. | A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in d |
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Get your free API keyRead the docsData 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.