FDA.reportPublic FDA data

EdgeFill for EdgeFile

Primary DI
10819514025488
Brand
EdgeFill for EdgeFile
Company
US ENDODONTICS, LLC
Model
X32506O
Catalog number
X32506O
Device description
Gutta percha plastic carrier obturator
Published
2023-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
00819514025481PrimaryGS10
10819514025488Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819514025481008195140254818195140254810819514025481
1081951402548810819514025488

GMDN Terms#

Term, Definition table
TermDefinition
Warm-bonded endodontic obturation system obturatorA hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(423)283-0047Bobby.bennett@us-endo.com

Regulatory Flags#

DUNS number
061317427
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10810047645358EdgeSequel UtopiaES150421SEES150421SE2023-07-28
10810047645365EdgeSequel UtopiaES150425SEES150425SE2023-07-28
10810047645372EdgeSequel UtopiaES150431SEES150431SE2023-07-28
10810047645389EdgeSequel UtopiaES250421SEES250421SE2023-07-28
10810047645396EdgeSequel UtopiaES250425SEES250425SE2023-07-28
10810047645402EdgeSequel UtopiaES250431SEES250431SE2023-07-28
10810047645419EdgeSequel UtopiaES300421SEES300421SE2023-07-28
10810047645426EdgeSequel UtopiaES300425SEES300425SE2023-07-28
10810047645433EdgeSequel UtopiaES300431SEES300431SE2023-07-28
10810047645440EdgeSequel UtopiaES400421SEES400421SE2023-07-28
10810047645457EdgeSequel UtopiaES400425SEES400425SE2023-07-28
10810047645464EdgeSequel UtopiaES400431SEES400431SE2023-07-28
10810047645471EdgeSequel UtopiaES500421SEES500421SE2023-07-28
10810047645488EdgeSequel UtopiaES500425SEES500425SE2023-07-28
10810047645495EdgeSequel UtopiaES500431SEES500431SE2023-07-28
10810047645501EdgeSequel UtopiaES250621SEES250621SE2023-07-28
10810047645518EdgeSequel UtopiaES250625SEES250625SE2023-07-28
10810047645525EdgeSequel UtopiaES250631SEES250631SE2023-07-28
10810047645532EdgeSequel UtopiaES300621SEES300621SE2023-07-28
10810047645549EdgeSequel UtopiaES300625SEES300625SE2023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06978880221119ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
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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