Fixed-Detachable Abutment 260-300-004

GUDID 00813110022189

4.0 x 5.0mm 0° Fixed-Detachable Abutment - 3.0mm Post

BICON, LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00813110022189
NIH Device Record Key9df611ad-634d-421d-8ea0-81f0d6920be9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixed-Detachable Abutment
Version Model Number260-300-004
Catalog Number260-300-004
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813110022189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-03-08

On-Brand Devices [Fixed-Detachable Abutment]

008131100222024.0 x 5.0mm 15° Fixed-Detachable Abutment - 3.0mm Post
008131100221964.0 x 3.0mm 15° Fixed-Detachable Abutment - 3.0mm Post
008131100221894.0 x 5.0mm 0° Fixed-Detachable Abutment - 3.0mm Post
008131100221724.0 x 3.0mm 0° Fixed-Detachable Abutment - 3.0mm Post
008131100217484.0 x 5.0mm 15° Fixed-Detachable Abutment - 2.5mm Post
008131100217174.0 x 3.0mm 15° Fixed-Detachable Abutment - 2.5mm Post
008131100217004.0 x 5.0mm 0° Fixed-Detachable Abutment - 2.5mm Post
008131100216944.0 x 3.0mm 0° Fixed-Detachable Abutment - 2.5mm Post
008131100205294.0 x 5.0mm 15° Fixed-Detachable Abutment - 2.0mm Post
008131100205054.0 x 3.0mm 15° Fixed-Detachable Abutment - 2.0mm Post
008131100204994.0 x 5.0mm 0° Fixed-Detachable Abutment - 2.0mm Post
008131100204824.0 x 3.0mm 0° Fixed-Detachable Abutment - 2.0mm Post

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