Fixed-Detachable Universal Abutment 260-252-315

GUDID 00813110028365

4mm FDUA SP 15° - 2.5mm Standard Post

BICON, LLC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID00813110028365
NIH Device Record Key9736ef6f-0b29-4910-bc40-19f387fd9c9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixed-Detachable Universal Abutment
Version Model Number260-252-315
Catalog Number260-252-315
Company DUNS945015758
Company NameBICON, LLC
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 Usetrue
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

Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813110028365 [Primary]
GS100813110028365 [Primary]
GS100813110028365 [Primary]
GS100813110028365 [Primary]
GS100813110028365 [Primary]
GS100813110028365 [Primary]
GS100813110028365 [Primary]
GS100813110028365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Fixed-Detachable Universal Abutment]

008131100285014mm FDUA TP 15° - 3.0mm Tall Post
008131100284954mm FDUA TP 0° - 3.0mm Tall Post
008131100284884mm FDUA SP 15° - 3.0mm Tall Post
008131100284714mm FDUA SP 0° - 3.0mm Tall Post
008131100284644mm FDUA TP 15° - 3.0mm Standard Post
008131100284574mm FDUA TP 0° - 3.0mm Standard Post
008131100284404mm FDUA SP 15° - 3.0mm Standard Post
008131100284334mm FDUA SP 0° - 3.0mm Standard Post
008131100284264mm FDUA TP 15° - 2.5mm Tall Post
008131100284194mm FDUA TP 0° - 2.5mm Tall Post
008131100284024mm FDUA SP 15° - 2.5mm Tall Post
008131100283964mm FDUA SP 0° - 2.5mm Tall Post
008131100283894mm FDUA TP 15° - 2.5mm Standard Post
008131100283724mm FDUA TP 0° - 2.5mm Standard Post
008131100283654mm FDUA SP 15° - 2.5mm Standard Post
008131100283584mm FDUA SP 0° - 2.5mm Standard Post
008131100283414mm FDUA TP 15° - 2.0mm Tall Post
008131100283344mm FDUA TP 0° - 2.0mm Tall Post
008131100283274mm FDUA SP 15° - 2.0mm Tall Post
008131100283104mm FDUA SP 0° - 2.0mm Tall Post
008131100283034mm FDUA TP 15° - 2.0mm Standard Post
008131100282974mm FDUA TP 0° - 2.0mm Standard Post
008131100282804mm FDUA SP 15° - 2.0mm Standard Post
008131100282734mm FDUA SP 0° - 2.0mm Standard Post

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