FDA.report

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
227
Last updated
2026-01-13 14:47:20

Related Product Codes

CodeDeviceSpecialtyClassDevices
EKRPlugger, Root Canal, EndodonticDental1208
EATTester, PulpDental26
EMNScaler, PeriodonticDental14
EIYInstrument, Filling, Plastic, DentalDental13
FZTCutter, SurgicalGeneral, Plastic Surgery11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
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
08806387890522GENESYS / PACK TIP 50/04 KIT [V2, 1ea]Meta Biomed Co., Ltd.90522022-09-24
08806387890539GENESYS / PACK TIP 60/05 KIT [V2, 1ea]Meta Biomed Co., Ltd.90532022-09-24
08806387890546GENESYS / PACK TIP 60/05L KIT [V2, 1ea]Meta Biomed Co., Ltd.90542022-09-24
08806387890553GENESYS / FILL NEEDLE 23G KIT [V2, 2ea]Meta Biomed Co., Ltd.90552022-09-24
08806387890560GENESYS / FILL NEEDLE 25G KIT [V2, 2ea]Meta Biomed Co., Ltd.90562022-09-24
08806387890577GENESYS / FILL NEEDLE 23/25G KIT [V2, 2ea]Meta Biomed Co., Ltd.90572022-09-24
08806387890584GENESYS / FILL NEEDLE 23G KIT [V1, 2ea]Meta Biomed Co., Ltd.90582022-09-24
08806387890591GENESYS / FILL NEEDLE 25G KIT [V1, 2ea]Meta Biomed Co., Ltd.90592022-09-24
08806387890607GENESYS / FILL NEEDLE 23/25G KIT [V1, 2ea]Meta Biomed Co., Ltd.90602022-09-24
00810060723500Obturation Plugger, 0.3mm Berman Instruments LLCVP003 2022-09-22
00810060723517Obturation Plugger, 0.4mm Berman Instruments LLCVP004 2022-09-22