FL-BOND II 1307

GUDID E23513070

FL BOND II PRIMER

SHOFU DENTAL CORPORATION

Dentine bonding agent/set
Primary Device IDE23513070
NIH Device Record Key57cf73dd-683c-487e-a464-309d8e4e22cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameFL-BOND II
Version Model Number1307
Catalog Number1307
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
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23513070 [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 Number4
Public Version Date2018-08-09
Device Publish Date2016-09-26

On-Brand Devices [FL-BOND II]

E23513090FL BOND II ETCHANT
E23513080FL BOND II BONDING
E23513070FL BOND II PRIMER
E23513060FL BOND II KIT

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