TSI/ERI/Macro Custom Abutment 3.25 TSI CA-HC

GUDID D785325TSICAHC0

TSI/ERI Transmucosal Healing Abutment 3.25mm 3.25mm Diameter

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD785325TSICAHC0
NIH Device Record Key8f518f0a-b2b9-41e2-b0cc-d55288b1c046
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSI/ERI/Macro Custom Abutment
Version Model NumberTSI/ERI Transmucosal Healing Abutment 3.25mm
Catalog Number3.25 TSI CA-HC
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
HIBCCD785325TSICAHC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


[D785325TSICAHC0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-08

On-Brand Devices [TSI/ERI/Macro Custom Abutment]

D7856TSICAHC0TSI/ERI Transmucosal Healing Abutment 6mm 6mm Diameter
D7856009406mm Bio-Torq Octagon Tip 6mm Diameter
D7855TSICAHC0TSI/ERI Transmucosal Healing Abutment 5mm 5mm Diameter
D7855IPUCLATSI60TSI/ERI UCLA Impression Pickup 6mm 6mm Diameter
D7855IPUCLATSI0TSI/ERI UCLA Impression Pickup 5mm 5mm Diameter
D7855009405mm Bio-Torq Octagon Tip 5mm Diameter
D7854TSICAHC0TSI/ERI Transmucosal Healing Abutment 4mm 4mm Diameter
D7854IPUCLATSI0TSI/ERI UCLA Impression Pickup 4mm 4mm Diameter
D7854CATA60TSI/ERI Transmucosal Abutment 6mm 6mm Diameter
D7854CATA50TSI/ERI Transmucosal Abutment 5mm 5mm Diameter
D7854CATA0Transmucosal Abutment 4mm 4mm Diameter
D7854009404mm Bio-Torq Octagon Tip 4mm Diameter
D785325TSICAHC0TSI/ERI Transmucosal Healing Abutment 3.25mm 3.25mm Diameter
D785325IPUCLATSI0TSI/ERI UCLA Impression Pickup 3.25mm 3.25mm Diameter
D785325CATA0TSI/ERI Transmucosal Abutment 3.25mm 3.25mm Diameter
D785325008403.25mm Bio-Torq Octagon Tip 3.25mm Diameter

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