Two Stage Bone Level Dental Implant 5016 ENGAGE

GUDID D7855016ENGAGE0

Two Stage Bone Level Dental Implant: 5.0mm Diameter X 16mm Length

OCO BIOMEDICAL INC

Screw endosteal dental implant, two-piece
Primary Device IDD7855016ENGAGE0
NIH Device Record Key4cbf1f00-bbf8-4467-aee5-e4f8b0db12e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwo Stage Bone Level Dental Implant
Version Model NumberEngage
Catalog Number5016 ENGAGE
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
HIBCCD7855016ENGAGE0 [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 Date2016-03-14

On-Brand Devices [Two Stage Bone Level Dental Implant ]

D7856016ENGAGE0Two Stage Bone Level Dental Implant: 6.0mm Diameter X 16mm Length
D7856014ENGAGE0Two Stage Bone Level Dental Implant: 6.0mm Diameter X 14mm Length
D7856012ENGAGE0Two Stage Bone Level Dental Implant: 6.0mm Diameter X 12mm Length
D7856010ENGAGE0Two Stage Bone Level Dental Implant: 6.0mm Diameter X 10mm Length
D7856008ENGAGE0Two Stage Bone Level Dental Implant: 6.0mm Diameter X 8mm Length
D7856006ENGAGE0Two Stage Bone Level Dental Implant: 6.0mm Diameter X 6mm Length
D7855016ENGAGE0Two Stage Bone Level Dental Implant: 5.0mm Diameter X 16mm Length
D7855014ENGAGE0Two Stage Bone Level Dental Implant: 5.0mm Diameter X 14mm Length
D7855012ENGAGE0Two Stage Bone Level Dental Implant: 5.0mm Diameter X 12mm Length
D7855010ENGAGE0Two Stage Bone Level Dental Implant: 5.0mm Diameter X 10mm length
D7855008ENGAGE0Two Stage Bone Level Dental Implant: 5.0mm Diameter X 8mm length
D7854016ENGAGE0Two Stage Bone Level Dental Implant : 4.0mm Diameter X 16mm Length
D7854014ENGAGE0Two Stage Bone Level Dental Implant: 4.0mm Diameter X 14mm Length
D7854012ENGAGE0Two Stage Bone Level Dental Implant: 4.0MM Diameter X 12mm Length
D7854010ENGAGE0Two Stage Bone Level Dental Implant: 4.0mm Diameter X 10mm length
D7854008ENGAGE0Two Stage Bone Level Dental Implant: 4.0mm Diameter X 8mm Length
D78532516ENGAGE0Two Stage Bone Level Dental Implant: 3.25mm Diameter X 16mm Length
D78532514ENGAGE0Two Stage Bone Level Dental Implant: 3.25mm Diameter X 14mm Length
D78532512ENGAGE0Two Stage Bone Level Dental Implant: 3.25mm Diameter X 12mm Length
D78532510ENGAGE0Two Stage Bone Level Dental Implant: 3.25mm Diameter X 10mm Length
D78532508ENGAGE0Two Stage Bone Level Dental Implant: 3.25mm Diameter X 8mm Length

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