HybenX 103-2001

GUDID 00813110027337

HybenX OTD Syringe (2-Pack)

BICON, LLC

Root canal cleaning solution Root canal cleaning solution
Primary Device ID00813110027337
NIH Device Record Keyc7b3a5eb-4435-4692-a1ea-9938aaf05523
Commercial Distribution StatusIn Commercial Distribution
Brand NameHybenX
Version Model Number103-2001
Catalog Number103-2001
Company DUNS945015758
Company NameBICON, LLC
Device Count2
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 Batchfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813110027337 [Primary]
GS100813110027825 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KJJCleanser, Root Canal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-06
Device Publish Date2016-11-01

Devices Manufactured by BICON, LLC

00813110029485 - Temporary Abutment2024-01-23 7.0mm Thin Crestal Temporary Abutment - 3.0mm Tall Post
00813110029577 - Temporary Abutment2023-10-10 5.0 x 6.5mm Scannable Temporary Abutment - 3.0mm Tall Post
00813110029553 - Pliers2023-07-13 Diamond Pliers
00813110029560 - Tweezers2023-07-13 Titanium Tweezers
00813110029539 - Instrument2023-07-11 Mesh Screwdriver
00813110029546 - Screw2023-07-11 Mesh Retention Screw (2)
00813110029508 - Temporary Abutment2023-06-15 4.0 x 4.5mm Scannable Temporary Abutment - 2.0mm Tall Post
00813110029515 - Coping2023-05-09 UA5 LP Retentive Ring (2)

Trademark Results [HybenX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYBENX
HYBENX
78583357 3230986 Live/Registered
EPIEN MEDICAL, INC.
2005-03-09

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