FDA.reportPublic FDA data

Manual endodontic file/rasp, single-use

Definition
A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a single-use device.
GUDID devices
4,595
Last updated
2026-07-30 21:31:47

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850085821171K FileCREATIVE ENDODONTIC TECHNOLOGY LLCKF-06-21MM-6PK2026-07-21
00850085821188K FileCREATIVE ENDODONTIC TECHNOLOGY LLCKF-08-21MM-6PK2026-07-21
00850085821195K FileCREATIVE ENDODONTIC TECHNOLOGY LLCKF-10-21MM-6PK2026-07-21
00850085821201H FilesCREATIVE ENDODONTIC TECHNOLOGY LLCHF-15-21MM-6PK2026-07-21
008101265003043D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21082023-02-13
008101265003113D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21102023-02-13
008101265003283D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21152023-02-13
008101265003353D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN2115-402023-02-13
008101265003423D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21202023-02-13
008101265003593D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21252023-02-13
008101265003663D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21302023-02-13
008101265003733D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21352023-02-13
008101265003803D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21402023-02-13
008101265003973D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21452023-02-13
008101265004033D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN2145-802023-02-13
008101265004103D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21502023-02-13
008101265004273D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21552023-02-13
008101265004343D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21602023-02-13
008101265004413D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21702023-02-13
008101265004583D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN21802023-02-13
008101265004653D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN25082023-02-13
008101265004723D Endo3D DENTAL DESIGNS AND DEVELOPMENT, LLCHN25102023-02-13
00810213810002EdgeEndoHSG-S Corp.EUCF6212026-03-23
00810213810019EdgeEndoHSG-S Corp.EUCF8212026-03-23
00810213810026EdgeEndoHSG-S Corp.EUCF10212026-03-23
00810213810033EdgeEndoHSG-S Corp.EUCF15212026-03-23
00810213810040EdgeEndoHSG-S Corp.EUCF6252026-03-23
00810213810057EdgeEndoHSG-S Corp.EUCF8252026-03-23
00810213810064EdgeEndoHSG-S Corp.EUCF10252026-03-23
00810213810071EdgeEndoHSG-S Corp.EUCF15252026-03-23
00810213810088EdgeEndoHSG-S Corp.EUKF6212026-03-23
00810213810095EdgeEndoHSG-S Corp.EUKF8212026-03-23
00810213810101EdgeEndoHSG-S Corp.EUKF10212026-03-23
00810213810118EdgeEndoHSG-S Corp.EUKF15212026-03-23
00810213810125EdgeEndoHSG-S Corp.EUKF20212026-03-23
00810213810132EdgeEndoHSG-S Corp.EUKF25212026-03-23
00810213810149EdgeEndoHSG-S Corp.EUKF30212026-03-23
00810213810156EdgeEndoHSG-S Corp.EUKF35212026-03-23
00810213810163EdgeEndoHSG-S Corp.EUKF40212026-03-23
00810213810170EdgeEndoHSG-S Corp.EUKF45212026-03-23
00810213810187EdgeEndoHSG-S Corp.EUKF50212026-03-23
00810213810194EdgeEndoHSG-S Corp.EUKF55212026-03-23
00810213810200EdgeEndoHSG-S Corp.EUKF60212026-03-23
00810213810217EdgeEndoHSG-S Corp.EUKF70212026-03-23
00810213810224EdgeEndoHSG-S Corp.EUKF80212026-03-23
00810213810231EdgeEndoHSG-S Corp.EUKF1035212026-03-23
00810213810248EdgeEndoHSG-S Corp.EUKF6252026-03-23
00810213810255EdgeEndoHSG-S Corp.EUKF8252026-03-23
00810213810262EdgeEndoHSG-S Corp.EUKF10252026-03-23
00810213810279EdgeEndoHSG-S Corp.EUKF15252026-03-23
00810213810286EdgeEndoHSG-S Corp.EUKF20252026-03-23
00810213810293EdgeEndoHSG-S Corp.EUKF25252026-03-23
00810213810309EdgeEndoHSG-S Corp.EUKF30252026-03-23
00810213810316EdgeEndoHSG-S Corp.EUKF35252026-03-23
00810213810323EdgeEndoHSG-S Corp.EUKF40252026-03-23
00810213810330EdgeEndoHSG-S Corp.EUKF45252026-03-23
00810213810347EdgeEndoHSG-S Corp.EUKF50252026-03-23
00810213810354EdgeEndoHSG-S Corp.EUKF55252026-03-23
00810213810361EdgeEndoHSG-S Corp.EUKF60252026-03-23
00810213810378EdgeEndoHSG-S Corp.EUKF70252026-03-23
00810213810385EdgeEndoHSG-S Corp.EUKF80252026-03-23
00810213810392EdgeEndoHSG-S Corp.EUKF1035252026-03-23
00818365025541Edge K-File™US ENDODONTICS, LLCNITIKF15212023-06-25
00818365025558Edge K-File™US ENDODONTICS, LLCNITIKF15252023-06-25
00818365025565Edge K-File™US ENDODONTICS, LLCNITIKF15312023-06-25
00818365025572Edge K-File™US ENDODONTICS, LLCNITIKF20212023-06-25
00818365025589Edge K-File™US ENDODONTICS, LLCNITIKF20252023-06-25
00818365025596Edge K-File™US ENDODONTICS, LLCNITIKF20312023-06-25
00818365025602Edge K-File™US ENDODONTICS, LLCNITIKF25212023-06-25
00818365025619Edge K-File™US ENDODONTICS, LLCNITIKF25252023-06-25
00818365025626Edge K-File™US ENDODONTICS, LLCNITIKF25312023-06-25
00818365025633Edge K-File™US ENDODONTICS, LLCNITIKF30212023-06-25
00818365025640Edge K-File™US ENDODONTICS, LLCNITIKF30252023-06-25
00818365025657Edge K-File™US ENDODONTICS, LLCNITIKF30312023-06-25
00818365025664Edge K-File™US ENDODONTICS, LLCNITIKF35212023-06-25
00818365025671Edge K-File™US ENDODONTICS, LLCNITIKF35252023-06-25
00818365025688Edge K-File™US ENDODONTICS, LLCNITIKF35312023-06-25
00818365025695Edge K-File™US ENDODONTICS, LLCNITIKF40212023-06-25
00818365025701Edge K-File™US ENDODONTICS, LLCNITIKF40252023-06-25
00818365025718Edge K-File™US ENDODONTICS, LLCNITIKF40312023-06-25