Healing Plug 260-100-025

GUDID 00813110020512

2.5mm Healing Plug Inserter

BICON, LLC

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00813110020512
NIH Device Record Keya19abf6d-7476-43ab-923f-274ee6b7e3d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealing Plug
Version Model Number260-100-025
Catalog Number260-100-025
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
GS100813110020512 [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 Number4
Public Version Date2018-12-07
Device Publish Date2016-03-10

On-Brand Devices [Healing Plug]

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00813110024114Healing Plug Removal Tool - Latch
00813110024107Healing Plug Removal Tool - Manual
008131100205122.5mm Healing Plug Inserter
008131100204752.0mm Healing Plug Inserter
008131100204683.0mm Healing Plug Inserter
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