Two-Stage Dental Implant 4010 TSI

GUDID D7854010TSI0

Two-Stage Dental Implant: 4.0mm Diameter X 10mm Length

OCO BIOMEDICAL INC

Screw endosteal dental implant, two-piece
Primary Device IDD7854010TSI0
NIH Device Record Key88d94029-640e-4241-bdb0-f88ab95b5246
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwo-Stage Dental Implant
Version Model NumberTSI
Catalog Number4010 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7854010TSI0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-03-10

On-Brand Devices [Two-Stage Dental Implant]

D7856012MACRO0Two-Stage Dental Implant: 6.0mm Diameter X 12mm length
D7856010MACRO0Two-Stage Dental Implant: 6.0mm Diameter X 10mm Length
D7856008MACRO0Two-Stage Dental Implant: 6.0mm Diameter X 8mm Length
D7856006MACRO0Two-Stage Dental Implant: 6.0mm Diameter X 6.0mm Length
D7855016TSI0Two-Stage Dental Implant: 5.0mm Diameter X 16mm Length
D7855016ERI0Two-Stage Dental Implant: 5.0mm Diameter X 16mm Length
D7855014TSI0Two-Stage Dental Implant: 5.0mm Diameter X 14mm Length
D7855012TSI0Two-Stage Dental Implant: 5.0mm Diameter X 12mm Length
D7855012ERI0Two-Stage Dental Implant: 5.0mm Diameter X 12mm Length
D7855010TSI0Two-Stage Dental Implant: 5.0mm Diameter X 10mm Length
D7855010ERI0Two-Stage Dental Implant: 5.0mm Diameter X 10mm Length
D7855008TSI0Two-Stage Dental Implant: 5.0mm Diameter X 8mm Length
D7855008ERI0Two-Stage Dental Implant: 5.0mm Diameter X 8mm Length
D7854016TSI0Two-Stage Dental Implant: 4.0mm Diameter X 16mm Length
D7854016ERI0Two-Stage Dental Implant: 4.0mm Diameter X 16mm Length
D7854014TSI0Two-Stage Dental Implant: 4.0mm Diameter X 14mm Length
D7854014ERI0Two-Stage Dental Implant: 4.0mm Diameter X 14mm Length
D7854012TSI0Two-Stage Dental Implant: 4.0mm Diameter X 12mm Length
D7854012ERI0Two-Stage Dental Implant: 4.0mm Diameter X 12mm Length
D7854010TSI0Two-Stage Dental Implant: 4.0mm Diameter X 10mm Length
D7854010ERI0Two-Stage Dental Implant: 4.0mm Diameter X 10mm Length
D7854008TSI0Two-Stage Dental Implant: 4.0mm Diameter X 8mm Length
D7854008ERI0Two-Stage Dental Implant: 4.0mm Diameter X 8mm Length
D78532516TSI0Two-Stage Dental Implant: 3.25mm Diameter X 16mm Length
D78532516ERI0Two-Stage Dental Implant: 3.25mm Diameter X 16mm length
D78532514TSI0Two-Stage Dental Implant: 3.25mm Diameter X 14mm Length
D78532514ERI0Two-Stage Dental Implant: 3.25mm Diameter X 14mm length
D78532512TSI0Two-Stage Dental Implant: 3.25mm Diameter X 12mm Length
D78532512ERI0Two-Stage Dental Implant: 3.25mm Diameter X 12mm Length
D78532510TSI0Two-Stage Dental Implant: 3.25mm Diameter X 10mm Length
D78532510ERI0Two-Stage Dental Implant: 3.25mm Diameter X 10mm Length
D78532508TSI0Two-Stage Dental Implant: 3.25mm Diameter X 8mm Length
D78532508ERI0Two-Stage Dental Implant: 3.25mm Diameter X 8mm length

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