FDA.reportPublic FDA data

Endodontic Hand Instruments

Primary DI
D80905325006R1
Brand
Endodontic Hand Instruments
Company
ROYDENT DENTAL PRODUCTS INC
Model
05325006R
Catalog number
05325006R
Device description
K-Reamer Size 006 25mm
Published
2022-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EKPREAMER, PULP CANAL, ENDODONTIC

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D80905325006R1PrimaryHIBCC0
D80905325006R0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
131487225
Device count
6
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D80906319015R1Endodontic Hand Instruments06319015R06319015R2022-11-29
D80906319015R0Endodontic Hand Instruments06319015R06319015R2022-11-29
D80906319010R1Endodontic Hand Instruments06319010R06319010R2022-11-10
D80906319010R0Endodontic Hand Instruments06319010R06319010R2022-11-10
D80906319020R1Endodontic Hand Instruments06319020R06319020R2022-11-09
D80906319025R1Endodontic Hand Instruments06319025R06319025R2022-11-09
D80906319160R1Endodontic Hand Instruments06319160R06319160R2022-11-09
D80906321006R1Endodontic Hand Instruments06321006R06321006R2022-11-09
D80906321008R1Endodontic Hand Instruments06321008R06321008R2022-11-09
D80906321010R1Endodontic Hand Instruments06321010R06321010R2022-11-09
D80906321012R1Endodontic Hand Instruments06321012R06321012R2022-11-09
D80906321015R1Endodontic Hand Instruments06321015R06321015R2022-11-09
D80906321017R1Endodontic Hand Instruments06321017R06321017R2022-11-09
D80906321020R1Endodontic Hand Instruments06321020R06321020R2022-11-09
D80906321025R1Endodontic Hand Instruments06321025R06321025R2022-11-09
D80906321030R1Endodontic Hand Instruments06321030R06321030R2022-11-09
D80906321035R1Endodontic Hand Instruments06321035R06321035R2022-11-09
D80906321040R1Endodontic Hand Instruments06321040R06321040R2022-11-09
D80906321045R1Endodontic Hand Instruments06321045R06321045R2022-11-09
D80906321050R1Endodontic Hand Instruments06321050R06321050R2022-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630049902770Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990104Reamer 29mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990128Reamer 29mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990142Reamer 29mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990166Reamer 29mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990180Reamer 29mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990203Reamer 29mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990227Reamer 29mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990241Reamer 29mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990265Reamer 29mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990289Reamer 29mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990302Reamer 29mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990326Reamer 29mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990340Reamer 29mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990364Reamer 29mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996595Reamer 21mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996601Reamer 21mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996618Reamer 21mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996625Reamer 21mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996632Reamer 21mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996649Reamer 21mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996656Reamer 21mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996663Reamer 21mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996670Reamer 21mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996687Reamer 21mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996694Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996700Reamer 21mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996717Reamer 21mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996724Reamer 21mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996731Reamer 25mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02