FDA.reportPublic FDA data

Dental material cartridge-plunging applicator, single-component

Definition
A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.
GUDID devices
60
Last updated
2026-07-30 21:31:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840456200940JMUJMU DENTAL, INC101070042026-07-20
00840456216743JMUJMU DENTAL, INC301040042026-07-20
00840456218198JMUJMU DENTAL, INC301040052026-07-20
00840456218204JMUJMU DENTAL, INC301040062026-07-20
00325047000005DMGDMG AMERICA, LLC2206002025-11-06
03701398101894Biodentine Applicator (Gun)SEPTODONT SAS SPECIALITES SEPTODONT01C07302022-12-13
03701398108503Biodentine Applicator (Gun) SEPTODONT SAS SPECIALITES SEPTODONT01C07302024-12-01
07615208437980Cavifil InjectorIVOCLAR VIVADENT AKTIENGESELLSCHAFT627882AN2022-11-17
D010606065961Capsule Extruder 2Dentsply De Trey GmbH606065962020-12-16
D832906CDG20PlasdentPLASDENT CORPORATION906CDG22026-05-01
D832906CDG30PlasdentPLASDENT CORPORATION906CDG32026-05-01
D8691300001AdDentADDENT, INC.Compex HD2026-04-22
00813909013350Dental Cartridge DispenserNOVABONE PRODUCTS, LLCND36002025-04-25
07898078650134SPEED GUNAngelus Industria de Produtos Odontologicos S ASPEED GUN 1 unit2025-03-20
07898078657423SPEED GUNAngelus Industria de Produtos Odontologicos S ASPEED GUN Kit2025-03-20
07898078659427EdgeUtopia RRM Dispensing GunAngelus Industria de Produtos Odontologicos S AEdgeUtopia RRM Dispensing Gun - 1 unit2025-03-20
00359883004101Compo-Ject™DEN-MAT HOLDINGS, LLC1601012025-03-12
00359883006341Compo-Pen™DEN-MAT HOLDINGS, LLC1601032025-03-12
00840326423783AstekYoung Innovations, Inc.11650UNODENT2025-02-19
00840326423790AstekYoung Innovations, Inc.11651UNODENT2025-02-19
00840326423806AstekYoung Innovations, Inc.11652UNODENT2025-02-19
03701398108510Biodentine Applicator (Gun) SEPTODONT SAS SPECIALITES SEPTODONT01C07302024-12-01
EDMG2228291Safetip Dispenser ProDMG Chemisch-Pharmazeutische Fabrik GmbH2228292024-07-12
B356BF165110American MedicalsAmerican Medicals12024-04-28
B356BF165130American MedicalsAmerican Medicals12024-04-28
00817051021881Mark ICENTRIX, INC.1106152023-12-29
00817051021898EZCENTRIX, INC.1307152023-12-29
00817051021904Snap FitCENTRIX, INC.1316502023-12-29
00817051021911Mark IICENTRIX, INC.1406152023-12-29
00817051022871EZCENTRIX, INC.9140402023-12-29
00817051023564Snap FitCENTRIX, INC.1306502023-12-29
00817051023663Mark ICENTRIX, INC.1100002023-12-29
00817051023694Mark IIICENTRIX, INC.1306002023-12-29
00817051023700Snap FitCENTRIX, INC.1306512023-12-29
00817051023724EZCENTRIX, INC.1307002023-12-29
00817051023731EZCENTRIX, INC.1307302023-12-29
00817051023748Mark IICENTRIX, INC.1400002023-12-29
00817051023823Snap FitCENTRIX, INC.9150432023-12-29
00817051023885EZCENTRIX, INC.9140152023-12-29
00348783002034Traxodent TipsPREMIER DENTAL PRODUCTS COMPANY90070892022-06-29
D010606659001Compules Tips GunDentsply De Trey GmbH606659002023-08-10
J014660197480KulzerKulzer GmbH660197482023-07-19
00817051023830MultiMatchPREMIER DENTAL PRODUCTS COMPANY30052202023-01-20
00889989075267OrmcoORMCO CORPORATION740-02002022-12-07
07615208434057Cavifil InjectorIVOCLAR VIVADENT AKTIENGESELLSCHAFT627882AN2022-11-17
D0026351051Caulk® Compules® Tips GunDENTSPLY INTERNATIONAL INC.6351052016-09-23
B35682602180American MedicalsAmerican Medicals12022-09-14
D0026351110Dentsply CaulkDENTSPLY INTERNATIONAL INC.6351112022-08-24
D6919007089PremierPREMIER DENTAL PRODUCTS COMPANY90070892022-06-29
07640368191366COMPOSITE TIP DISPENSERColtène/Whaledent AG600224852022-05-08
D832IT8ACT0PlasdentPLASDENT CORPORATIONIT8-ACT2022-02-01
D832IT8APP0PlasdentPLASDENT CORPORATIONIT8-APP2022-02-01
D832906CDG10P0PlasdentPLASDENT CORPORATION906CDG-10P2022-01-28
D832906CDG110PlasdentPLASDENT CORPORATION906CDG-112022-01-28
D832906CDG2P0PlasdentPLASDENT CORPORATION906CDG-2P2022-01-28
D832906CDG4X0PlasdentPLASDENT CORPORATION906CDG-4X2022-01-28
D832906CDG7X0PlasdentPLASDENT CORPORATION906CDG-7X2022-01-28
D832906CDG9L0PlasdentPLASDENT CORPORATION906CDG-9L2022-01-28
D779100GUN1Compule GunCOSMEDENT, INC.100GUN2021-10-26
D757X80801P1Unit Dose Dispensing SyringeBISCO INC.X-80801P2018-11-06