Home › Device types › EBC
Sealant, Pit And Fissure, And Conditioner
FDA product code EBC · Class 2 · Dental
536
Registered devices
57
Adverse events
3
Recalls
131
510(k) clearances
Devices with this code
RIVA PROTECT — SDI LIMITEDNovaPro — NANOVA BIO MATERIALS INCSEPTODONT TOOTHFAIRY BPA FREE P&F SEA= — SEPTODONT, INCRIVA PROTECT — SDI LIMITEDSciPharm Pit & Fissure Sealer Bonding Agent, White, Part A, Box — SCIENTIFIC PHARMACEUTICALS, INC.Helioseal/Clear/F/F Plus — IVOCLAR VIVADENT AKTIENGESELLSCHAFTBeautiSealant — SHOFU DENTAL CORPORATIONCapo Flow A 2, 2 g — Schütz Dental GmbHPIT AND FISSURE SEALANT OP — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCORTHOSOURCE — ORTHOSOURCEVENUS Diamond FLOW PLT 20x0,20g - HKA5 — Kulzer GmbHRIVA CONDITIONER — SDI LIMITEDVENUS Diamond FLOW PLT 20x0,20g - B2 — Kulzer GmbHNuSmile NuNamel Pit & Fissure Sealant — NUSMILE, LTD.IQ Dental — IQ DENTAL SUPPLY LLCBioCoat — PREMIER DENTAL PRODUCTS COMPANYORTHOSOURCE — ORTHOSOURCECONSEAL — SDI LIMITEDCapo Slow Flow A 2, 2 g — Schütz Dental GmbHDuo-Link Universal — BISCO INC.SciPharm Pit & Fissure Sealer Bonding Agent — SCIENTIFIC PHARMACEUTICALS, INC.Champ — CENTRIX, INC.NanoPaq B 3, 4 g — Schütz Dental GmbHVENUS Diamond FLOW — Kulzer GmbH
Recent 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 64 |
| 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 |
| 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 |
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