Bone Level Implant Abutment 4035-3SA

GUDID D78540353SA0

4mm Straight Abutment 4mm Diameter 3mm Collar

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD78540353SA0
NIH Device Record Keyfb880a4b-a714-43df-b21c-d07a1077d74a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Level Implant Abutment
Version Model Number4mm Straight Abutment
Catalog Number4035-3SA
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
HIBCCD78540353SA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


[D78540353SA0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-11

On-Brand Devices [Bone Level Implant Abutment]

D7856057PA06mm Peek Temporary Straight Abutment 6mm Diameter
D7856057CAA06mm Custom Angled 15 Degree Abutment 6mm Diameter
D78560573SA06mm Straight Abutment 6mm Diameter 3mm Collar
D78560572SA06mm Straight Abutment 6mm Diameter 2mm Collar
D78560572OB06mm O-Ball Abutment 6mm Diameter 2mm Collar
D78560572CB06mm Crown & Bridge Abutment 6mm Diameter 2mm Collar For multiple unit restorations only (not fo
D78560571SA06mm Straight Abutment 6mm Diameter 1mm Collar
D78560571OB06mm O-Ball Abutment 6mm Diameter 1mm Collar
D7855045PA05mm PEEK Temporart Straight Abutment 5mm Diameter
D7855045CAA05mm Custom Angled 15 Degree Abutment 5mm Diameter
D78550454OB05mm O-Ball Abutment 5mm Diameter 4mm Collar
D78550453SA05mm Straight Abutment 5mm Diameter 3mm Collar
D78550453OB05mm O-Ball Abutment 5mm Diameter 3mm Collar
D78550452SA05mm Straight Abutment 5mm Diameter 2mm Collar
D78550452OB05mm O-Ball Abutment 5mm Diameter 2mm Collar
D78550452CB05mm Crown & Bridge Abutment 5mm Diameter 2mm Collar For multiple unit restorations only (not for
D78550451SA05mm Straight Abutment 5mm Diameter 1mm Collar
D7854035PA04mm PEEK Temporary Straight Abutment 4mm Diameter
D7854035CAA04mm Custom Angled 15 Degree Abutment 4mm Diameter
D78540354OB04mm O-Ball Abutment 4mm Diameter 4mm Collar
D78540353SA04mm Straight Abutment 4mm Diameter 3mm Collar
D78540353OB04mm O-Ball Abutment 4mm Diameter 3mm Collar
D78540352SA04mm Straight Abutment 4mm Diameter 2mm Collar
D78540352OB04mm O-Ball Abutment 4mm Diameter 2mm Collar
D78540352CB04mm Crown & Bridge Abutment 4mm Diameter 2mm Collar For multiple unit restorations only (not for
D78540351SA04mm Straight Abutment 4mm Diameter 1mm Collar
D78532530PA03.25mm PEEK Temporary Straight Abutment 3.25mm Diameter
D78532530CAA03.25mm Custom Angled 15 Degree Abutment 3.25mm Diameter
D785325304OB03.25mm O-Ball Abutment 3.25mm Diameter 4mm Collar
D785325303SA03.25mm Straight Abutment 3.25mm Diameter 3mm Collar
D785325303OB03.25mm O-Ball Abutment 3.25mm Diameter 3mm Collar
D785325302SA03.25mm Straight Abutment 4mm Diameter 2mm Collar
D785325302OB03.25mm O-Ball Abutment 3.25mm Diameter 2mm Collar
D785325302CB03.25mm Crown & Bridge Abutment 3.25mm Diameter 2mm Collar For multiple unit restorations only (n
D785325301SA03.25mm Straight Abutment 3.25mm Diameter 1mm Collar
D785325301CB03.25mm Crown & Bridge Abutment 3.25mm Diameter 1mm Collar For multiple unit restorations only (n

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