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Activator, Ultraviolet, For Polymerization

FDA product code EBZ · Class 2 · Dental

700
Registered devices
171
Adverse events
4
Recalls
214
510(k) clearances

Devices with this code

Bluephase G4 — IVOCLAR VIVADENT AKTIENGESELLSCHAFTBluephase G4 — IVOCLAR VIVADENT AKTIENGESELLSCHAFTAdvanced Endodontic System — ASI MEDICAL, INC.Henry ScheinMaxima — HENRY SCHEIN, INC.Aurora™ — PARKELL, INC.BENCO — BENCO DENTAL SUPPLY CO.DTE — Guilin Woodpecker Medical Instrument Co., Ltd.LEDEX — DENTMATE TECHNOLOGY CO., LTD.SmartLite® Pro Modular LED Curing Light — DENTSPLY INTERNATIONAL INC.Dentronix — DENTRONIX INCFlight Dental Systems — Flight Dental SystemsParkell® — PARKELL, INC.ACTEON — SATELECAPOZA — APOZA ENTERPRISE CO., LTD.WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.LEDEX — DENTMATE TECHNOLOGY CO., LTD.Valo X — ULTRADENT PRODUCTS, INC.LEDEX — DENTMATE TECHNOLOGY CO., LTD.Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCBluephase G4 — IVOCLAR VIVADENT AKTIENGESELLSCHAFTColtolux — COLTENE/WHALEDENT INCLUXITE — ITENA CLINICALLight Guide — Kerr Corporation

Recent recalls

DateFirmReason
2022-01-20Envisiontec US LlcThe PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
2018-04-04Handpiece HeadquartersTip of the curing light was too hot causing a heat sensation in the patients.
2014-04-14Ivoclar Vivadent, Inc.A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
2012-04-23O'Ryan Industries IncDisposa-Shield Disposable Curing Shield is recalled due to lacking 510K, PMA or IDE, and inadequate quality system.

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