Bone Level Locator Abutment 8671

GUDID D7858671LA0

5mm Locator Abutment 5mm Diameter 0mm Height

OCO BIOMEDICAL INC

Dental implant system

Primary Device ID	D7858671LA0
NIH Device Record Key	7eaa5f2b-f52c-4064-80fb-13c13847d5fc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Bone Level Locator Abutment
Version Model Number	5mm Locator Abutment
Catalog Number	8671
Company DUNS	094146123
Company Name	OCO BIOMEDICAL INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7858671LA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090174

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

[D7858671LA0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-04-13

On-Brand Devices [Bone Level Locator Abutment]

D7858675LA0	5mm Locator Abutment 5mm Diameter 4.5mm Height
D7858674LA0	5mm Locator Abutment
D7858673LA0	5mm Locator Abutment 5mm Diameter 2.5mm Height
D7858672LA0	5mm Locator Abutment 5mm Diameter 1mm Height
D7858671LA0	5mm Locator Abutment 5mm Diameter 0mm Height
D7858665LA0	4mm Locator Abutment 4mm Diameter 4.5mm Height
D7858664LA0	4mm Locator Abutment 4mm Diameter 3.5mm Height
D7858663LA0	4mm Locator Abutment 4mm Diameter 2.5mm Height
D7858662LA0	4mm Locator Abutment 4mm Diameter 1mm Height
D7858661LA0	4mm Locator Abutment 4mm Diameter 0mm Height
D7858628LA0	5mm Locator Abutment 5mm Diameter 6.5mm Height
D7858627LA0	5mm Locator Abutment 5mm Diameter 5.5mm Height
D7858626LA0	4mm Locator Abutment 4mm Diameter 6.5mm Height
D7858625LA0	4mm Locator Abutment 4mm Diameter 5.5mm Height
D7851713LA0	3.25mm Locator Abutment 3.25mm Diameter 6mm Height
D7851712LA0	3.25mm Locator Abutment 3.25mm Diameter 5mm Height
D7851711LA0	3.25mm Locator Abutment 3.25mm Diameter 4mm Height
D7851710LA0	3.25mm Locator Abutment 3.25mm Diameter 3mm Height
D7851709LA0	3.25mm Locator Abutment 3.25mm Diameter 2mm Height
D7851708LA0	3.25mm Locator Abutment 3.25mm Diameter 1mm Height
D7851707LA0	3.25mm Locator Abutment 3.25mm Diameter 0mm Height
D7851476LA0	6mm Locator Abutment 6mm Diameter 6.5mm Height
D7851475LA0	6mm Locator Abutment 6mm Diameter 5.5mm Height
D7851474LA0	6mm Locator Abutment 6mm Diameter 4.5mm Height
D7851473LA0	6mm Locator Abutment 6mm Diameter 3.5mm Height
D7851472LA0	6mm Locator Abutment 6mm Diameter 2.5mm Height
D7851471LA0	6mm Locator Abutment 6mm Diameter 1mm Height

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