PEEK Temporary Abutment 260-250-765

GUDID 00813110027931

5.0 x 6.5mm PEEK Temporary Abutment - 2.5mm Post

BICON, LLC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00813110027931
NIH Device Record Keyb2c88315-38a5-42d1-ac89-ca705e86898f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEEK Temporary Abutment
Version Model Number260-250-765
Catalog Number260-250-765
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
GS100813110027931 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-12-07
Device Publish Date2018-07-17

On-Brand Devices [PEEK Temporary Abutment]

008131100280377.5 x 6.5mm PEEK Temporary Abutment - 3.0mm Post
008131100280207.5 x 4.5mm PEEK Temporary Abutment - 3.0mm Post
008131100280136.5 x 6.5mm PEEK Temporary Abutment - 3.0mm Post
008131100280066.5 x 4.5mm PEEK Temporary Abutment - 3.0mm Post
00813110027993PEEK 5.0 x 6.5mm Temporary Abutment - 3.0mm Post
008131100279865.0 x 4.5mm PEEK Temporary Abutment - 3.0mm Post
008131100279794.0 x 6.5mm PEEK Temporary Abutment - 3.0mm Post
008131100279624.0 x 4.5mm PEEK Temporary Abutment - 3.0mm Post
008131100279556.5 x 6.5mm PEEK Temporary Abutment - 2.5mm Post
008131100279486.5 x 4.5mm PEEK Temporary Abutment - 2.5mm Post
008131100279315.0 x 6.5mm PEEK Temporary Abutment - 2.5mm Post
008131100279245.0 x 4.5mm PEEK Temporary Abutment - 2.5mm Post
008131100279174.0 x 6.5mm PEEK Temporary Abutment - 2.5mm Post
008131100279004.0 x 4.5mm PEEK Temporary Abutment - 2.5mm Post
008131100278945.0 x 6.5mm PEEK Temporary Abutment - 2.0mm Post
008131100278875.0 x 4.5mm PEEK Temporary Abutment - 2.0mm Post
008131100278704.0 x 6.5mm PEEK Temporary Abutment - 2.0mm Post
008131100278634.0 x 4.5mm PEEK Temporary Abutment - 2.0mm Post

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.