FDA.reportPublic FDA data

Zarc

Primary DI
06978880221812
Brand
Zarc
Company
Shanghai Xing Yu Medical Equipment Co.,Ltd.
Model
Z30-Z50/assorted/60pc
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
EKMGutta-Percha

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978880221812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978880221812069788802218126978880221812

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""]"
Hydrogen Peroxide;Liquid Chemical

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
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
08800069213302GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213319GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213326GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213333GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213340GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213357GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213364GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213371GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213388GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213395GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213401GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213418GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213425GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213432GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213449GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213456GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213104Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213111Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213128Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213135Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069204775B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204782B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204799B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069205000B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204805XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204812XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204829XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204836XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204843XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204669MinikutSURE DENT CORPORATIONEKM2023-09-06