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Activator, Ultraviolet, For Polymerization
FDA product code EBZ · Class 2 · Dental
709
Registered devices
171
Adverse events
4
Recalls
214
510(k) clearances
Devices with this code
RADII — SDI LIMITEDDTE — Guilin Woodpecker Medical Instrument Co., Ltd.Loop™ — GARRISON DENTAL SOLUTIONS, L.L.C.Parkell® — PARKELL, INC.VALO — ULTRADENT PRODUCTS, INC.Advanced Endodontic System — ASI MEDICAL, INC.Valo X — ULTRADENT PRODUCTS, INC.VALO — ULTRADENT PRODUCTS, INC.VALO — ULTRADENT PRODUCTS, INC.Advanced Endodontic System — ASI MEDICAL, INC.VALO — ULTRADENT PRODUCTS, INC.PinkWave Kit — Vista DentalLED CORDLESS CURING LIGHT — BONART CO., LTD.SmartLite® Pro Modular LED Curing Light — DENTSPLY INTERNATIONAL INC.Ascent OL5 Curing Light — CAO GROUP, INC.SOLEIL — BENCO DENTAL SUPPLY CO.Starlight pro — Kulzer GmbHWOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.Sapphire® Plus — DEN-MAT HOLDINGS, LLCLoop™ — GARRISON DENTAL SOLUTIONS, L.L.C.BLUEPHASE STYLE 20I — IVOCLAR VIVADENT AKTIENGESELLSCHAFTWOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.Bluephase G4 — IVOCLAR VIVADENT AKTIENGESELLSCHAFTLight Guide — Kerr Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-20 | Envisiontec US Llc | The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. |
| 2018-04-04 | Handpiece Headquarters | Tip of the curing light was too hot causing a heat sensation in the patients. |
| 2014-04-14 | Ivoclar Vivadent, Inc. | A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes. |
| 2012-04-23 | O'Ryan Industries Inc | Disposa-Shield Disposable Curing Shield is recalled due to lacking 510K, PMA or IDE, and inadequate quality system. |
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