Fixed-Detachable Universal Abutment Component 260-100-130

GUDID 00813110028518

FDUA Analog (2)

BICON, LLC

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00813110028518
NIH Device Record Key30cf6a93-535d-4266-8f64-2ccc63af074c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixed-Detachable Universal Abutment Component
Version Model Number260-100-130
Catalog Number260-100-130
Company DUNS945015758
Company NameBICON, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
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
GS100813110028518 [Primary]
GS100813110028518 [Primary]
GS100813110028518 [Primary]
GS100813110028518 [Primary]
GS100813110028518 [Primary]
GS100813110028518 [Primary]
GS100813110028518 [Primary]
GS100813110028518 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous
NDPAccessories, Implant, Dental, Endosseous
NDPAccessories, Implant, Dental, Endosseous
NDPAccessories, Implant, Dental, Endosseous
NDPAccessories, Implant, Dental, Endosseous
NDPAccessories, Implant, Dental, Endosseous
NDPAccessories, Implant, Dental, Endosseous
NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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 Component]

00813110028532FDUA Coping (2)
00813110028525FDUA Transfer Coping (2)
00813110028518FDUA Analog (2)

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