4.0/5.0/6.0mm O-Ball Abutment 4 OB 0TSI

GUDID D7854OB0TSI0

4.0/5.0/6.0mm Fixed Solid O-Ball Abutment 0mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD7854OB0TSI0
NIH Device Record Key1b27605f-bdc0-45dd-95ed-9944b9b1ff56
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.0/5.0/6.0mm O-Ball Abutment
Version Model NumberTSI/ERI/Macro O-Ball Abutment
Catalog Number4 OB 0TSI
Company DUNS094146123
Company NameOCO BIOMEDICAL INC
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7854OB0TSI0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


[D7854OB0TSI0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-03-21

On-Brand Devices [4.0/5.0/6.0mm O-Ball Abutment]

D7854OB4TSI04.0/5.0/6.0mm Fixed Solid O-Ball Abutment 4mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants
D7854OB3TSI04.0/5.0/6.0mm Fixed Solid O-Ball Abutment 3mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants
D7854OB2TSI04.0/5.0/6.0 Fixed Solid O-Ball Abutment 2mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants
D7854OB0TSI04.0/5.0/6.0mm Fixed Solid O-Ball Abutment 0mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants

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