Simple Line II SOXTD4333

GUDID 08809162706544

Accessories, Implant, Dental, Endosseous

Dentium Co., Ltd.

Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable
Primary Device ID08809162706544
NIH Device Record Key23ad57e2-995b-4a8f-9bf3-e853e0310955
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimple Line II
Version Model NumberSOXTD4333
Catalog NumberSOXTD4333
Company DUNS689514395
Company NameDentium Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Dimensions

Outer Diameter4.3 Millimeter
Length33 Millimeter
Outer Diameter4.3 Millimeter
Length33 Millimeter
Outer Diameter4.27 Millimeter
Length33 Millimeter
Outer Diameter4.3 Millimeter
Length33 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108809162706544 [Primary]

FDA Product Code

EJLBUR, DENTAL
NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809162706544]

Moist Heat or Steam Sterilization


[08809162706544]

Moist Heat or Steam Sterilization


[08809162706544]

Moist Heat or Steam Sterilization


[08809162706544]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-25
Device Publish Date2020-05-14

On-Brand Devices [Simple Line II]

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08809460302318Abutment, Implant, Dental, Endosseous
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