Bone Level Abutment 4035-3MUA (Angled 30)

GUDID D78540353MUA0

4mm Multi Unit Abutment 30 Degree Angle 4mm Diameter 3mm Height 3.5mm Platform

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD78540353MUA0
NIH Device Record Keyc3f8cdcf-9076-4f05-963f-e36115265ca1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Level Abutment
Version Model Number4mm Multi Unit Abutment 30 Degree Angle
Catalog Number4035-3MUA (Angled 30)
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
HIBCCD78540353MUA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


[D78540353MUA0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-20

On-Brand Devices [Bone Level Abutment]

D78550455MUA505mm Multi Unit Abutment 5mm Diameter 5mm Height 4.5mm Platform
D78550455MUA3005mm Multi Unit Abutment 30 Degree 5mm Diameter 5mm Height 4.5mm Platform
D78550455MUA05mm Multi Unit Abutment 17 Degree 5mm Diameter 5mm Height 4.5mm Height
D78550454MUA3005mm Multi Unit Abutment 30 Degree 5mm Diameter 3mm Height 4.5mm Platform
D78550453MUA305mm Multi Unit Abutment 5mm Diameter 3mm Height 4.5mm Platform
D78550453MUA05mm Multi Unit Abutment 17 Degree 5mm Diameter 3mm Height 4.5mm Platform
D78550452MUA205mm Multi Unit Abutment 5mm Diameter 2mm Height 4.5mm Platform
D78550452MUA05mm Multi Unit Abutment 17 Degree 5mm Diameter 2mm Height 4.5mm Platform
D78550451MUA05mm Multi Unit Abutment 5mm Diameter 1mm Height 4.5mm Platform
D78540353MUA1704mm Multi Unit Abutment 17 Degree 4mm Diameter 3mm Height 3.5mm Platform
D78540353MUA04mm Multi Unit Abutment 30 Degree Angle 4mm Diameter 3mm Height 3.5mm Platform
D78540352MUA1704mm Multi Unit Abutment 17 Degree 4mm Diameter 2mm Height 3.5mm Platform
D78540352MUA04mm Multi Unit Abutment 4mm Diameter 2mm Height 3.5mm Platform
D78540351MUA04mm Multi Unit Abutment 4mm Diameter 1mm Height 3.5mm Platform

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.