NR Line GHAB653545

GUDID 08809691363522

Abutment, Implant, Dental, Endosseous

Dentium Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08809691363522
NIH Device Record Key825c8a58-3cec-4706-8473-33d68359707d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNR Line
Version Model NumberGHAB653545
Catalog NumberGHAB653545
Company DUNS689514395
Company NameDentium Co., Ltd.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(714)226-0229
Emailcs@dentiumusa.com
Phone+1(714)226-0229
Emailcs@dentiumusa.com
Phone+1(714)226-0229
Emailcs@dentiumusa.com
Phone+1(714)226-0229
Emailcs@dentiumusa.com
Phone+1(714)226-0229
Emailcs@dentiumusa.com
Phone+1(714)226-0229
Emailcs@dentiumusa.com
Phone+1(714)226-0229
Emailcs@dentiumusa.com

Device Dimensions

Length10.1 Millimeter
Outer Diameter6.5 Millimeter
Length10.1 Millimeter
Outer Diameter6.5 Millimeter
Length10.1 Millimeter
Outer Diameter6.5 Millimeter
Length10.1 Millimeter
Outer Diameter6.5 Millimeter
Length10.1 Millimeter
Outer Diameter6.5 Millimeter
Length10.1 Millimeter
Outer Diameter6.5 Millimeter
Length10.1 Millimeter
Outer Diameter6.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108809691363522 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-02
Device Publish Date2020-05-25

On-Brand Devices [NR Line]

08809460306569Endosseous dental implant abutment
08809460306552Endosseous dental implant abutment
08809460306545Endosseous dental implant abutment
08809460306538Endosseous dental implant abutment
08809460306521Endosseous dental implant abutment
08809460306514Endosseous dental implant abutment
08809460306507Endosseous dental implant abutment
08809460306491Endosseous dental implant abutment
08809460306484Endosseous dental implant abutment
08809460306477Endosseous dental implant abutment
08809460306460Endosseous dental implant abutment
08809460306453Endosseous dental implant abutment
08809460306446Endosseous dental implant abutment
08809460306439Endosseous dental implant abutment
08809460306422Endosseous dental implant abutment
08809460306415Endosseous dental implant abutment
08809460306408Endosseous dental implant abutment
08809460306392Endosseous dental implant abutment
08809460306385Endosseous dental implant abutment
08809460306378Endosseous dental implant abutment
08809460306361Endosseous dental implant abutment
08809460306354Endosseous dental implant abutment
08809460306347Endosseous dental implant abutment
08809460306330Endosseous dental implant abutment
08809460306323Endosseous dental implant abutment
08809460306316Endosseous dental implant abutment
08809460306309Endosseous dental implant abutment
08809460306293Endosseous dental implant abutment
08809460306286Endosseous dental implant abutment
08809460306279Endosseous dental implant abutment
08809460306262Endosseous dental implant abutment
08809460306255Endosseous dental implant abutment
08809460306248Endosseous dental implant abutment
08809460306231Endosseous dental implant abutment
08809460306224Endosseous dental implant abutment
08809460306002Endosseous dental implant abutment
08809460305999Endosseous dental implant abutment
08809460305982Endosseous dental implant abutment
08809460305975Endosseous dental implant abutment
08809460305968Endosseous dental implant abutment
08809460305951Endosseous dental implant abutment
08809460305944Endosseous dental implant abutment
08809460305937Endosseous dental implant abutment
08809460305920Endosseous dental implant abutment
08809460305913Endosseous dental implant abutment
08809460305906Endosseous dental implant abutment
08809460305890Endosseous dental implant abutment
08809460305883Endosseous dental implant abutment
08809460305876Endosseous dental implant abutment
08809460305869Endosseous dental implant abutment

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