FDA.reportPublic FDA data

AVALON BIOMED

Primary DI
06978880222994
Brand
AVALON BIOMED
Company
Shanghai Xing Yu Medical Equipment Co.,Ltd.
Model
XF/180pc
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
06978880222994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978880222994069788802229946978880222994

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529128752
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978880220006ZarcT0.02/15#/200pc2026-03-09
06978880220013ZarcT0.02/20#/200pc2026-03-09
06978880220020ZarcT0.02/25#/200pc2026-03-09
06978880220037ZarcT0.02/30#/200pc2026-03-09
06978880220044ZarcT0.02/35#/200pc2026-03-09
06978880220051ZarcT0.02/40#/200pc2026-03-09
06978880220068ZarcT0.02/15#-40#/assorted/200pc2026-03-09
06978880220075ZarcT0.02/45#/200pc2026-03-09
06978880220082ZarcT0.02/50#/200pc2026-03-09
06978880220099ZarcT0.02/55#/200pc2026-03-09
06978880220105ZarcT0.02/60#/200pc2026-03-09
06978880220112ZarcT0.02/70#/200pc2026-03-09
06978880220129ZarcT0.02/80#/200pc2026-03-09
06978880220136ZarcT0.02/45#-80#/assorted/200pc2026-03-09
06978880220143ZarcT0.02/90#/100pc2026-03-09
06978880220150ZarcT0.02/100#/100pc2026-03-09
06978880220167ZarcT0.02/90#-140#/assorted/100pc2026-03-09
06978880220174ZarcT0.04/15#/100pc2026-03-09
06978880220181ZarcT0.04/20#/100pc2026-03-09
06978880220198ZarcT0.04/25#/100pc2026-03-09

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