FDA.reportPublic FDA data

Roydent Absortbent paper Points Zipperer

Primary DI
D8090560020Z0
Brand
Roydent Absortbent paper Points Zipperer
Company
ROYDENT DENTAL PRODUCTS INC
Model
0560020Z
Catalog number
0560020Z
Device description
Absorbent Points (standard/sterile)
Published
2022-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EKNPOINT, PAPER, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8090560020Z1PrimaryHIBCC0
D8090560020Z0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131487225
Device count
180
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D80906319015R0Endodontic Hand Instruments06319015R06319015R2022-11-29
D80906319010R0Endodontic Hand Instruments06319010R06319010R2022-11-10
D80906319020R0Endodontic Hand Instruments06319020R06319020R2022-11-09
D80906319025R0Endodontic Hand Instruments06319025R06319025R2022-11-09
D80906319160R0Endodontic Hand Instruments06319160R06319160R2022-11-09
D80906321006R0Endodontic Hand Instruments06321006R06321006R2022-11-09
D80906321008R0Endodontic Hand Instruments06321008R06321008R2022-11-09
D80906321010R0Endodontic Hand Instruments06321010R06321010R2022-11-09
D80906321012R0Endodontic Hand Instruments06321012R06321012R2022-11-09
D80906321015R0Endodontic Hand Instruments06321015R06321015R2022-11-09
D80906321017R0Endodontic Hand Instruments06321017R06321017R2022-11-09
D80906321020R0Endodontic Hand Instruments06321020R06321020R2022-11-09
D80906321025R0Endodontic Hand Instruments06321025R06321025R2022-11-09
D80906321030R0Endodontic Hand Instruments06321030R06321030R2022-11-09
D80906321035R0Endodontic Hand Instruments06321035R06321035R2022-11-09
D80906321040R0Endodontic Hand Instruments06321040R06321040R2022-11-09
D80906321045R0Endodontic Hand Instruments06321045R06321045R2022-11-09
D80906321050R0Endodontic Hand Instruments06321050R06321050R2022-11-09
D80906321055R0Endodontic Hand Instruments06321055R06321055R2022-11-09
D80906321060R0Endodontic Hand Instruments06321060R06321060R2022-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978880220006ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220013ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220020ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220037ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220044ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220051ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220068ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220075ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220082ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220099ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220105ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220112ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220129ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220136ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220143ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220150ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220167ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220174ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220181ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220198ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220204ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220211ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220228ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220235ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220242ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220259ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220266ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220273ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220280ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220297ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09