Endo-Eze MTAFlow Repair Cement Refill US 3981-US

GUDID 00883205031723

Endo-Eze MTAFlow Repair Cement Refill US

ULTRADENT PRODUCTS, INC.

Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement
Primary Device ID00883205031723
NIH Device Record Key9caa2dcf-c053-4bb3-b463-cd820de729b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo-Eze MTAFlow Repair Cement Refill US
Version Model Number3981-US
Catalog Number3981-US
Company DUNS013369913
Company NameULTRADENT PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com
Phone801-572-4200
Emailcustomerservice@ultradent.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205031723 [Primary]

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-17

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00883205034205 - VALO2024-03-04 VALO X Diffuser Lens 1pk
00883205027948 - PermaShade Try-In Paste2024-01-19 PermaShade Try-In Paste Kit
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