Bone Level Healing Abutment 5045-5HA

GUDID D78550455HA0

5mm Healing Abutment 5mm Diameter 5mm Height

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD78550455HA0
NIH Device Record Key594d9c31-a1fd-4dcb-83a1-01dfb98fe150
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Level Healing Abutment
Version Model Number5mm Healing Abutment
Catalog Number5045-5HA
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
HIBCCD78550455HA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


[D78550455HA0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-13

On-Brand Devices [Bone Level Healing Abutment]

D78560575HA06mm Healing Abutment 6mm Diameter 5mm Height
D78560573HA06mm Healing Abutment 6mm Diameter 3mm Height
D78550455HA05mm Healing Abutment 5mm Diameter 5mm Height
D78550453HA05mm Healing Abutment 5mm Diameter 3mm Height
D78540355HA04mm Healing Abutment 4mm Diameter 5mm Height
D78540353HA04mm Healing Abutment 4mm Diameter 3mm Height
D785325305HA03.25mm Healing Abutment 3.25mm Diameter 5mm Height
D785325303HA03.25mm Healing Abutment 3.25mm Diameter 3mm Height

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