FDA.reportPublic FDA data

AVALON BIOMED

Primary DI
06978880223502
Brand
AVALON BIOMED
Company
Shanghai Xing Yu Medical Equipment Co.,Ltd.
Model
T0.06/20#/60pc
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EKMGutta-Percha

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978880223502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978880223502069788802235026978880223502

GMDN Terms#

Term, Definition table
TermDefinition
Natural gutta-perchaA dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide;Liquid Chemical

Regulatory Flags#

DUNS number
529128752
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
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
06978880221102ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221119ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221126ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221133ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221140ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221157ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221164ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221171ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221188ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221195ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221201ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221218ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221225ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221232ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221249ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221256ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221263ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221270ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221287ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221294ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221300ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221317ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221324ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221331ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221348ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221355ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221362ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221379ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221386ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221393ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09