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Sealant, Pit And Fissure, And Conditioner

FDA product code EBC · Class 2 · Dental

535
Registered devices
57
Adverse events
3
Recalls
131
510(k) clearances

Devices with this code

NanoPaq C 2, 4 g — Schütz Dental GmbHHelioseal Clear — IVOCLAR VIVADENT AKTIENGESELLSCHAFTDELTON® — Dentsply ProfessionalPREVENT SEAL — ITENA CLINICALCapo Flow A 4, 2 g — Schütz Dental GmbHConstic A1 — DMG Chemisch-Pharmazeutische Fabrik GmbHVivid Seal Sealant material Low viscosity — PEARSON DENTAL SUPPLIES, INC.Health-Tec Pit & Fissure Sealant — Dental Health Products IncCapo Natural B 3, 4 g — Schütz Dental GmbHAdvance Dental Products — The Atlanta Dental Supply CompanyRIVA PROTECT — SDI LIMITEDEmail Preparator — IVOCLAR VIVADENT AKTIENGESELLSCHAFTUltraSeal XT — ULTRADENT PRODUCTS, INC.Choice 2 — BISCO INC.Embrace Wetbond Pit and Fissure Sealant — PULPDENT CORPORATIONSciPharm Pit & Fissure Sealer Bonding Agent — SCIENTIFIC PHARMACEUTICALS, INC.Helioseal — IVOCLAR VIVADENT AKTIENGESELLSCHAFTEmbrace Wetbond Low Fill — PULPDENT CORPORATIONHexa — Hexa DentalVisalys Flow — Kettenbach GmbH & Co. KGCapo Natural A 3.5, 4 g — Schütz Dental GmbHSeal-Rite™ — PULPDENT CORPORATIONCapo Natural Bleach 2, 4 g — Schütz Dental GmbHHelioseal F — IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Recent recalls

DateFirmReason
2016-11-17Ultradent 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 64
2016-02-12Ivoclar 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
2015-10-07Ivoclar 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.