FDA.reportPublic FDA data

Dental material application tool, reusable

Definition
A hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.
GUDID devices
273
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00348783008722Premier ApplicatorsPREMIER DENTAL PRODUCTS COMPANY10031152026-04-01
00348783008739Premier ApplicatorsPREMIER DENTAL PRODUCTS COMPANY10043972026-04-01
00348783008746Premier ApplicatorsPREMIER DENTAL PRODUCTS COMPANY10043962026-04-01
00348783009668Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10036922026-04-02
00348783009675Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10036932026-04-02
00348783009729Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037042026-04-02
00348783009736Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037052026-04-02
00348783009743Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037062026-04-02
00348783009750Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037072026-04-02
00348783009767Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037102026-04-02
00348783009774Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037182026-04-02
00348783009781Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037202026-04-02
00348783009798Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037212026-04-02
00348783009804Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037232026-04-02
00348783009811Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037242026-04-02
00348783009828Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037252026-04-02
00348783009835Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10037362026-04-02
00348783009842Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10038882026-04-02
00348783009866Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10038952026-04-02
00348783009873Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10038962026-04-02
00348783009880Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10038972026-04-02
00348783009910Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10039002026-04-02
00348783009927Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10039022026-04-02
00348783009941Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057002026-04-02
00348783009958Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057012026-04-02
00348783009965Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057022026-04-02
00348783009972Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057032026-04-02
00348783009989Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057042026-04-02
00348783009996Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057052026-04-02
00348783010008Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057062026-04-02
00348783010015Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057072026-04-02
00348783010022Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057082026-04-02
00348783010039Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY057092026-04-02
00883205033321Ultradent Composite GunULTRADENT PRODUCTS, INC.78002022-12-08
05713513001307COMPO-JECT 2.0 black handleRønvig Dental Manufacturing A/S200062026-04-14
10889950146405Hu-FriedyHU-FRIEDY MFG. CO., LLCTNFBL32025-11-03
10889950147891Hu-FriedyHU-FRIEDY MFG. CO., LLCCTNFF5/62026-02-24
10889950147907Hu-FriedyHU-FRIEDY MFG. CO., LLCCTNFF7/82026-02-24
10889950147914Hu-FriedyHU-FRIEDY MFG. CO., LLCCTNFF3/42026-02-24
10889950147921Hu-FriedyHU-FRIEDY MFG. CO., LLCCTNFF1/22026-02-24
B356KF251020American MedicalsAmerican Medicals12026-04-15
B356KF251040American MedicalsAmerican Medicals12026-04-15
D8387502T4Premium PlusPremium Plus International Limited7502T2020-01-08
EMICCHFF251Enamel Plus Hri FLOWMICERIUM SPACHFF252023-05-05
EMICTPENMP1Enamel Plus Stain & InstrumentsMICERIUM SPATPENMP2023-05-05
ESAM13307001STOMA®Storz am Mark GmbH13307.002020-08-27
ESAM14445001STOMA®Storz am Mark GmbH14445.002020-08-27
ESAM14612001STOMA®Storz am Mark GmbH14612.002020-08-27
ESAM14613001STOMA®Storz am Mark GmbH14613.002020-08-27
ESAM14616001STOMA®Storz am Mark GmbH14616.002020-08-27
ESAM14630001STOMA®Storz am Mark GmbH14630.002020-08-27
ESAM14634001STOMA®Storz am Mark GmbH14634.002020-08-27
ESAM14635001STOMA®Storz am Mark GmbH14635.002020-08-27
ESAM5318081STOMA®Storz am Mark GmbH5318.082020-08-27
00348783009859Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10038942026-03-17
00348783009897Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10038982026-03-17
00348783009903Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANY10038992026-03-17
08800019116608NeoGlide Resin InstrumentsB& L Biotech, inc.NGR#12025-06-18
08800019116615NeoGlide Resin InstrumentsB& L Biotech, inc.NGR#22025-06-18
00359883002947Dr. Ronald Jordan Composite Instrument Series REJ #01DEN-MAT HOLDINGS, LLC0601012025-03-12
00359883002954Dr. Ronald Jordan Composite Instrument Series REJ #02DEN-MAT HOLDINGS, LLC0601022025-03-12
00359883002961Dr. Ronald Jordan Composite Instrument Series REJ #03DEN-MAT HOLDINGS, LLC0601032025-03-12
00359883002978Dr. Ronald Jordan Composite Instrument Series REJ #04DEN-MAT HOLDINGS, LLC0601042025-03-12
00359883002985Dr. Ronald Jordan Composite Instrument Series REJ #10DEN-MAT HOLDINGS, LLC0601102025-03-12
00359883002992Dr. Ronald Jordan Composite Instrument Series REJ #21DEN-MAT HOLDINGS, LLC0601212025-03-12
00359883003005Dr. Ronald Jordan Composite Instrument Series REJ #22DEN-MAT HOLDINGS, LLC0601222025-03-12
00359883003012Esthetic Contouring Instruments Gold GripDEN-MAT HOLDINGS, LLC0631032025-03-12
00359883003029Esthetic Contouring Instruments Replacement Tip Gold Grip & Soft GripDEN-MAT HOLDINGS, LLC0631042025-03-12
00359883003036Esthetic Contouring Instruments Replacement Tip Blue GripDEN-MAT HOLDINGS, LLC0631072025-03-12
00359883006075Dr. Ronald Jordan Composite Instrument Series REJ #20DEN-MAT HOLDINGS, LLC0601202025-03-12
00359883006082Esthetic Contouring Instruments Blue GripDEN-MAT HOLDINGS, LLC0631062025-03-12
EMICTPENMC1Temp Silicon BrushMICERIUM SPATPENMC2024-08-06
00813677023612PDT, Inc.PDT, INC.T845 Bone Carrier (3.5mm)2024-07-02
00813677023629PDT, Inc.PDT, INC.T846 Bone Carrier (4.5mm)2024-07-02
00813677023636PDT, Inc.PDT, INC.T847 Bone Carrier (6mm)2024-07-02
00813677023711PDT, Inc.PDT, INC.T856 Bone Carrier Plugger (2 mm dia.) with Depth M2024-07-02
00813677023728PDT, Inc.PDT, INC.T857 Bone Carrier Plugger (3 mm dia.) with Safety 2024-07-02
00813677023735PDT, Inc.PDT, INC.T858 Bone Carrier Plugger (4 mm dia.) with Safety 2024-07-02
07908854000425Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDAS2002OP2024-05-23
07908854000432Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDAS2003OP2024-05-23