FDA.reportPublic FDA data

Roydent Absortbent paper Points Zipperer

Primary DI
D8090555XFZ0
Brand
Roydent Absortbent paper Points Zipperer
Company
ROYDENT DENTAL PRODUCTS INC
Model
0555XFZ
Catalog number
0555XFZ
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
D8090555XFZ1PrimaryHIBCC0
D8090555XFZ0Unit 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
200
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
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
08800069213463Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213470Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213487Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213494Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213500Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213517Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213524Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213531Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213548Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213555Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213562Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213579Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213586Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213593Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213609Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213616Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213142Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213159Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213166Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213173Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069204850XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204867XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204874XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204881XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204898XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069209497Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209503Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209510Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209527Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16
08800069209534Edge .04 PPSURE DENT CORPORATIONEKN2023-08-16