Zinc Phosphate 1171

GUDID E23511710

HY-BOND ZINC POWDER

SHOFU DENTAL CORPORATION

Zinc phosphate dental cement
Primary Device IDE23511710
NIH Device Record Key9153aa83-7222-4df9-b02d-31df75485970
Commercial Distribution StatusIn Commercial Distribution
Brand NameZinc Phosphate
Version Model Number1171
Catalog Number1171
Company DUNS054618202
Company NameSHOFU DENTAL CORPORATION
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

Phone760-566-3528
Emailckaemmerlen@shofu.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23511710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

On-Brand Devices [Zinc Phosphate]

E23511720HY-BOND ZINC LIQUID
E23511710HY-BOND ZINC POWDER

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