FDA.reportPublic FDA data

EndoREZ Points

Primary DI
00883205020703
Brand
EndoREZ Points
Company
ULTRADENT PRODUCTS, INC.
Model
1675
Catalog number
1675
Device description
EndoREZ Points 40 .02 Taper
Published
2018-02-07
Public version status
Update
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
00883205020703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205020703008832050207038832050207030883205020703

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

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
DM exempt
false
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
00883205042835Opalustre5545542026-03-10
00883205044068Enamelast690669062026-02-11
00883205044075Enamelast690769072026-02-11
00883205044082Enamelast691369132026-02-11
00883205044099Enamelast690869082026-02-11
00883205044105Enamelast690969092026-02-11
00883205044112Enamelast691069102026-02-11
00883205044129Enamelast691169112026-02-11
00883205044136Enamelast691269122026-02-11
00883205044983Porcelain Repair110811082026-01-30
00883205044372Valo X6496-DU6496-DU2025-12-04
00883205044389Valo X6497-DU6497-DU2025-12-04
00883205044396Valo X6498-DU6498-DU2025-12-04
00883205044402Valo X6499-DU6499-DU2025-12-04
00883205044419Valo X6519-DU6519-DU2025-12-04
00883205044426Valo X6538-DU6538-DU2025-12-04
00883205044143Enamelast689568952025-11-14
00883205044150Enamelast689668962025-11-14
00883205044167Enamelast689768972025-11-14
00883205044174Enamelast689868982025-11-14

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