Fixed-Detachable 260-100-039

GUDID 00813110029003

Fixed-Detachable Digital Abutment Analog Kit

BICON, LLC

Dental implant abutment analog, laboratory
Primary Device ID00813110029003
NIH Device Record Key93ff831b-ea72-4cec-a748-bb00653e0dea
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixed-Detachable
Version Model Number260-100-039
Catalog Number260-100-039
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
Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813110029003 [Primary]

FDA Product Code

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 Date2021-09-09
Device Publish Date2021-09-01

Devices Manufactured by BICON, LLC

00813110027276 - Universal Abutment2024-10-29 Universal Abutment UA6 SP 0° - 3.0mm Tall Post
00813110027283 - Universal Abutment2024-10-29 Universal Abutment UA6 SP 15° - 3.0mm Tall Post
00813110029744 - Scan Post2024-10-29 2.0mm Titanium Scan Post (2)
00813110029751 - Scan Post2024-10-29 2.5mm Titanium Scan Post (2)
00813110029768 - Scan Post2024-10-29 3.0mm Titanium Scan Post (2)
00813110029775 - Temporary Abutment2024-10-29 6.5 x 4.5mm Scannable Temporary Abutment - 3.0mm Tall Post
00813110029669 - Temporary Abutment2024-08-13 4.0 x 6.5mm Scannable Temporary Abutment - 3.0mm Post
00813110029676 - Temporary Abutment2024-08-13 4.0 x 4.5mm Scannable Temporary Abutment - 3.0mm Tall Post

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