FDA.reportPublic FDA data

K-Files 29mm 050, pu: 6 pcs

Primary DI
07630049987005
Brand
K-Files 29mm 050, pu: 6 pcs
Company
Diaswiss SA
Model
129029.050
Device description
Manual instrument for endodontic intraoral use
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630049987005PrimaryGS10
07630049986992Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630049987005076300499870057630049987005
07630049986992076300499869927630049986992

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480296552
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630049901063Porcelain Veneer Set1VeneerSetPD2023-12-01
07630049901087Porcelain Veneer Set1PhucDangSet2023-12-01
07630049901100A-Z Modern Cavity Set1ModernCavitySe2023-12-01
07630049901391RootEX standard 0.8 (sample)935L.Set008-sam2023-12-01
07630049901407RootEX standard 011(sample)935L.Set011-sam2023-12-01
07630049901414RootEX standard 1.6 (sample)935L.Set016-sam2023-12-01
07630049901421RootEX standard 1.8 (sample)935L.Set018-sam2023-12-01
07630049901438RootEX standard 0.8 (sample)935K.Set008-sam2023-12-01
07630049901452RootEX standard 1.1 (sample)935K.Set011-sam2023-12-01
07630049901469RootEX standard 1.6 (sample)935K.Set016-sam2023-12-01
07630049901483RootEX standard 1.8 (sample)935K.Set018-sam2023-12-01
07630049901490Phuc Dang Set21PhucDangSet22023-12-01
07630049901520Hedstroem files 25mm 045 - 080, pu: 6325025.45802023-12-01
07630049901537Reamer 31mm 45 - 80, pu: 6 pcs231031.45802023-12-01
076300499018721Dr.XochipaSet Full Prep Set1Dr.XochipaSet2023-12-01
07630049902817Surgicut Set314Z164-set.0152023-12-01
07630049902824Porcelain Adjustment Kit RA K011AdjustmentKit2023-12-01
07630049950894rootEX instrument set short, pu: 2 pcs937K.Set2023-12-01
07630049950979rootEX instrument set long, pu: 2 pcs937L.Set2023-12-01
07630049951006Set FG diamonds short shank1ShortSet2023-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810213812419EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812426EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812433EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812440EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812457EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812464EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812471EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812488EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812495EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812501EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812518EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812525EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812532EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812549EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812556EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812563EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812570EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812587EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812594EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812600EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812617EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812624EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812631EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812648EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812655EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812662EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812679EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812686EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812693EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812709EdgeEndoHSG-S Corp.EKS2026-06-24