FDA.reportPublic FDA data

rootEX drill short shank 1,3 mm, pu: 6

Primary DI
07630049952607
Brand
rootEX drill short shank 1,3 mm, pu: 6
Company
Diaswiss SA
Model
935K.013med
Device description
Rotary 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
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630049952607PrimaryGS10
07630049902404Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630049952607076300499526077630049952607
07630049902404076300499024047630049902404

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. 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 a rotary or engine file, or 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
07899878064985NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878064992NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065005NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065012NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065029NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065036NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065043NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065050NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065067NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065074NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065081NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065098NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065104NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065111NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
08056099233449VIVID POST DRILLBIOLOREN SRLDZA2024-03-21
07630049952614rootEX drill short shank 1,6 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952621rootEX drill short shank 1,8 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952683rootEX drill 0,8 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952690rootEX drill 1,1 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952706rootEX drill 1,3 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952713rootEX drill 1,6 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952720rootEX drill 1,8 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952782rootEX plug short 1,0 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952799rootEX plug short 1,3 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952805rootEX plug short 1,5 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952812rootEX plug short 1,8 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952829rootEX plug short 2,0 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952836rootEX plug 1,0 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952843rootEX plug 1,3 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952850rootEX plug 1,5 mm pu: 6 pcsDiaswiss SADZA2023-10-02