4.0/5.0/6.0mm Abutment 4CB 4 TSI

GUDID D7854CB4TSI0

4.0/5.0/6.0mm Fixed Solid Crown & Bridge Abutment 4.0mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD7854CB4TSI0
NIH Device Record Key42357591-5490-4f81-a243-a2724463ab0f
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.0/5.0/6.0mm Abutment
Version Model NumberTSI/ERI/Macro Abutment
Catalog Number4CB 4 TSI
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
HIBCCD7854CB4TSI0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

Moist Heat or Steam Sterilization


[D7854CB4TSI0]

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 Abutment]

D7854CB7TSI04.0/5.0/6.0mm Fixed Solid Crown & Bridge Abutment 7mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro
D7854CB55TSI04.0/5.0/6.0mm Fixed Solid Crown & Bridge Abutment 5.5mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro I
D7854CB4TSI04.0/5.0/6.0mm Fixed Solid Crown & Bridge Abutment 4.0mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro I

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