3.25 Abutment 3.25CB 4 TSI

GUDID D785325CB4TSI0

3.25mm Fixed Solid Crown & Bridge Abutment 4.0 mm Height For 3,25mm TSI/ERI Implants

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD785325CB4TSI0
NIH Device Record Key501bff34-032f-4465-b17d-09c8214cf281
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.25 Abutment
Version Model NumberTSI/ERI Abutment
Catalog Number3.25CB 4 TSI
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
HIBCCD785325CB4TSI0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


[D785325CB4TSI0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-03-21

On-Brand Devices [3.25 Abutment]

D785325CB7TSI03.25 Fixed Solid Crown & Bridge Abutment 7mm Height For TSI/ERI Implants
D785325CB55TSI03.25mm Fixed Solid Crown & Bridge Abutment 5.5mm Height For 3.25mm TSI/ERI Implants
D785325CB4TSI03.25mm Fixed Solid Crown & Bridge Abutment 4.0 mm Height For 3,25mm TSI/ERI Implants

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