NR Line GDAB5550AS(H)

GUDID 08809460305494

Endosseous dental implant abutment

Dentium Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08809460305494
NIH Device Record Key3b5729fb-17da-4acf-8b72-e515a782bc25
Commercial Distribution StatusIn Commercial Distribution
Brand NameNR Line
Version Model NumberGDAB5550AS(H)
Catalog NumberGDAB5550AS(H)
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 Datefalse
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
Phone+1(714)226-0229
Emailcs@dentiumusa.com
Phone+1(714)226-0229
Emailcs@dentiumusa.com

Device Dimensions

Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0
Outer Diameter5.5 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108809460305494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809460305494]

Moist Heat or Steam Sterilization


[08809460305494]

Moist Heat or Steam Sterilization


[08809460305494]

Moist Heat or Steam Sterilization


[08809460305494]

Moist Heat or Steam Sterilization


[08809460305494]

Moist Heat or Steam Sterilization


[08809460305494]

Moist Heat or Steam Sterilization


[08809460305494]

Moist Heat or Steam Sterilization


[08809460305494]

Moist Heat or Steam Sterilization


[08809460305494]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-30
Device Publish Date2021-08-20

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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