FDA.reportPublic FDA data

Endodontic obturation system

Definition
An assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.
GUDID devices
238
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840326418376Obtura SpartanYoung Innovations, Inc.823-8002022-10-06
00843471100417Obtura SpartanYoung Innovations, Inc.823-8032022-10-06
00843471100424Obtura SpartanYoung Innovations, Inc.823-8102022-10-06
00843471137475Obtura SpartanYoung Innovations, Inc.824-7002022-10-06
00843471150054Obtura SpartanYoung Innovations, Inc.824-7062022-10-06
00843471152799Obtura SpartanYoung Innovations, Inc.823-8042022-10-06
00889989068481System B HandpieceORMCO CORPORATION952-00082016-09-08
06979865810007Integrated Endo SystemDENJOY DENTAL CO.,LTDMeet Endo-II2026-03-31
10817417020166Dentsply SironaASEPTICO, INC.AEU-65-DS2022-12-08
J003TDDW1G1316OSH1WaveOne® Gold Orifice Shaper DemoMAILLEFER INSTRUMENTS HOLDING SàrlTDDW1G1316OSH2026-04-24
J003TSTW1G1316OSH1WaveOne® Gold Orifice ShaperMAILLEFER INSTRUMENTS HOLDING SàrlTSTW1G1316OSH2026-04-24
06941877827816ZarcChangzhou Sifary Medical Technology Co., Ltd.Z-Down2026-01-05
06941877827823ZarcChangzhou Sifary Medical Technology Co., Ltd.Z-Up2026-01-05
08806383586313DUO-GUNDiaDent Group InternationalDUO-GUN BATTERY(1BL250DIA-3)2025-03-12
08806383586320DUO-PENDiaDent Group InternationalDUO-PEN BATTERY(1BL250DIA-4)2025-03-12
06970873260389Integrated Endo SystemDENJOY DENTAL CO.,LTD Meet Endo-II2025-02-28
04260482991166EndoPilot D-Pack² handpieceSchlumbohm GmbH & Co. KGv042025-01-28
04260482991173EndoPilot² expansion DownPack²Schlumbohm GmbH & Co. KGv012025-01-28
08809455602164elements IC META SYSTEMS CO., LTD.Backfill2024-12-30
08809455602171elements ICMETA SYSTEMS CO., LTD.Downpack2024-12-30
08809455602188elements ICMETA SYSTEMS CO., LTD.Dual Charger2024-12-30
08809455602195elements ICMETA SYSTEMS CO., LTD.Single Charger2024-12-30
08809455602386elements ICMETA SYSTEMS CO., LTD.elements IC SYSTEM2024-12-30
08809455602393elements ICMETA SYSTEMS CO., LTD.elements IC DOWNPACK UNIT2024-12-30
08809455602409elements ICMETA SYSTEMS CO., LTD.elements IC BACKFILL UNIT2024-12-30
06974267890572COXOFoshan COXO Medical Instrument Co.,Ltd.C-FILL2024-12-18
06974267890718COXOFoshan COXO Medical Instrument Co.,Ltd.C-BLADE2024-12-18
08800019101581NeedleB& L Biotech, inc.BSN50202024-12-03
08800019102168NeedleB& L Biotech, inc.HSN22202024-12-03
08800019102175NeedleB& L Biotech, inc.HSN24202024-12-03
08800019102182NeedleB& L Biotech, inc.HSN28202024-12-03
08800019102199NeedleB& L Biotech, inc.HSN21232024-12-03
08800019102205NeedleB& L Biotech, inc.HSN24232024-12-03
08800019102212NeedleB& L Biotech, inc.HSN28232024-12-03
08800019102229NeedleB& L Biotech, inc.HSN22252024-12-03
08800019102236NeedleB& L Biotech, inc.HSN24252024-12-03
08800019102243NeedleB& L Biotech, inc.HSN26252024-12-03
08800019102250NeedleB& L Biotech, inc.HSN50202024-12-03
08800019102267NeedleB& L Biotech, inc.HMN24202024-12-03
08800019102274NeedleB& L Biotech, inc.HMN24232024-12-03
08800019102281NeedleB& L Biotech, inc.HMN24252024-12-03
08800019100478PluggerB& L Biotech, inc.HT30042024-12-02
08800019100485PluggerB& L Biotech, inc.HT35042024-12-02
08800019100492PluggerB& L Biotech, inc.HT40042024-12-02
08800019100508PluggerB& L Biotech, inc.HT45042024-12-02
08800019100515PluggerB& L Biotech, inc.HT5508L2024-12-02
08800019100522PluggerB& L Biotech, inc.HT50042024-12-02
08800019100539PluggerB& L Biotech, inc.HT55062024-12-02
08800019100546PluggerB& L Biotech, inc.HT55082024-12-02
08800019100553PluggerB& L Biotech, inc.HT55102024-12-02
08800019100560PluggerB& L Biotech, inc.HT60122024-12-02
08800019100577Hot Testing TipB& L Biotech, inc.HHTT2024-12-02
08800019102151NeedleB& L Biotech, inc.HSNSET2024-12-02
08800019100416HotTipB& L Biotech, inc.CL-A12024-11-19
08800019102014HotShotB& L Biotech, inc.BP-B12024-11-19
08800019100157PluggerB& L Biotech, inc.BP35042024-10-25
08800019100195PluggerB& L Biotech, inc.BP50042024-10-25
08800019101543NeedleB& L Biotech, inc.BSN28232024-10-25
06974267891197COXOFoshan COXO Medical Instrument Co.,Ltd.C-FILL MINI2024-07-04
06974267891203COXOFoshan COXO Medical Instrument Co.,Ltd.C-FILL MINI2024-07-04
06972597781621EighteethChangzhou Sifary Medical Technology Co., Ltd.Fast-Fill2024-03-25
06975132957345EighteethChangzhou Sifary Medical Technology Co., Ltd.Fast-Pack pro2024-03-25
04719883751300APOZAAPOZA ENTERPRISE CO., LTD.GP Easy II2023-06-26
10840326418373Obtura SpartanYoung Innovations, Inc.823-8002022-10-06
10843471100414Obtura SpartanYoung Innovations, Inc.823-8032022-10-06
10843471100421Obtura SpartanYoung Innovations, Inc.823-8102022-10-06
10843471137472Obtura SpartanYoung Innovations, Inc.824-7002022-10-06
10843471150051Obtura SpartanYoung Innovations, Inc.824-7062022-10-06
10843471152796Obtura SpartanYoung Innovations, Inc.823-8042022-10-06
08806387890331E&Q Master / Gun needle set [23G]Meta Biomed Co., Ltd.90332022-09-24
08806387890348E&Q Master / Gun needle set [25G]Meta Biomed Co., Ltd.90342022-09-24
08806387890409E&Q Master / Pen tip [F/FM]Meta Biomed Co., Ltd.90402022-09-24
08806387890447GENESYS / PACK TIP [F]Meta Biomed Co., Ltd.90442022-09-24
08806387890454GENESYS / PACK TIP [FM]Meta Biomed Co., Ltd.90452022-09-24
08806387890461GENESYS / PACK TIP [M]Meta Biomed Co., Ltd.90462022-09-24
08806387890478GENESYS / PACK TIP [ML]Meta Biomed Co., Ltd.90472022-09-24
08806387890485GENESYS / PACK TIP [XF]Meta Biomed Co., Ltd.90482022-09-24
08806387890492GENESYS / PACK TIP [F/FM]Meta Biomed Co., Ltd.90492022-09-24
08806387890508GENESYS / PACK TIP 50/40, 60/05 KIT [V2, 2ea]Meta Biomed Co., Ltd.90502022-09-24
08806387890515GENESYS / PACK TIP 40/03 KIT [V2, 1ea]Meta Biomed Co., Ltd.90512022-09-24