TSI/ERI/Macro Locator Abutment 8547

GUDID D7858547GREEN0

Locator Inserts-4 Pack Extended Range Replacement Male, 4lbs. (Green)

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD7858547GREEN0
NIH Device Record Key66c3e14c-7715-47d2-9425-bdea5d37e284
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSI/ERI/Macro Locator Abutment
Version Model NumberLocator Inserts-4 Pack
Catalog Number8547
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
HIBCCD7858547GREEN0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

Moist Heat or Steam Sterilization


[D7858547GREEN0]

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 Locator Abutment]

D785895560Locator Abutment 4mm 4mm Diameter 6mm Height
D785895450Locator Abutment 4mm 4mm Diameter 5mm height
D785895340Locator Abutment 4mm 4mm Diameter 4mm Height
D785895230Locator Abutment 4mm 4mm Diameter 3mm Height
D785895120Locator Abutment 4mm 4mm Diameter 2mm Height
D785895070Locator Abutment 4mm 4mm Diameter .7mm Height
D7858915ORANGE0Locator Inserts-4 Pack Extended Range Replacement Male, 2lbs. (Orange)
D7858548RED0Locator Inserts-4 Pack Extended Range Replacement Male, 3lbs. (Red)
D7858547GREEN0Locator Inserts-4 Pack Extended Range Replacement Male, 4lbs. (Green)
D7858529BLUE0Locator Inserts-4 Pack Replacement Male, 1.5lbs. (Blue)
D7858527PINK0Locator Inserts-4 Pack Replacement Male, Light Retention, 3lbs. (Pink)
D7858524CLEAR0Locator Inserts-4 Pack Replacement Male, 5lbs. (Clear)
D7858514BOS0Locator inserts-4 Pack Block Out Spacers
D785190260Locator Abutment 5/6mm 5/6mm Diameter 6mm Height
D785190150Locator Abutment 5/6mm 5/6mm Diameter 5mm Height
D785190040Locator Abutment 5/6mm 5/6mm Diameter 4mm Height
D785189930Locator Abutment 5/6mm 5/6mm Diameter 3mm Height
D785189820Locator Abutment 5/6mm 5/6mm Diameter 2mm Height
D785189760Locator Abutment 3.25mm 3.25mm Diameter 6mm Height
D785189650Locator Abutment 3.25mm 3.25mm Diameter 5mm Height
D785189540Locator Abutment 3.25mm 3.25mm Diameter 4mm Height
D785189430Locator Abutment 3.25mm 3.25mm Diameter 3mm Height
D785189320Locator Abutment 3.25mm 3.25mm Diameter 2mm Height
D785189270Locator Abutment 3.25mm 3.25mm Diameter .7mm Height

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