One Piece O-Ball Dental Implant ISI 4016 OB

GUDID D785ISI4016OB0

One Piece O-Ball Dental Implant: 4.0mm Diameter X 16mm length

OCO BIOMEDICAL INC

Screw endosteal dental implant, one-piece
Primary Device IDD785ISI4016OB0
NIH Device Record Keyc7173f00-6a5d-494c-a584-3d5cde62e12b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne Piece O-Ball Dental Implant
Version Model NumberO-Ball
Catalog NumberISI 4016 OB
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
HIBCCD785ISI4016OB0 [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 [One Piece O-Ball Dental Implant]

D785ISI5016OB0One Piece O-Ball Dental Implant: 5.0mm Diameter X 16mm length
D785ISI5014OB0One Piece O-Ball Dental Implant: 5.0mm Diameter X 14mm Length
D785ISI5012OB0One Piece O-Ball Dental Implant: 5.0mm Diameter X 12mm length
D785ISI5010OB0One Piece O-Ball Dental Implant: 5.0mm Diameter X 10mm Length
D785ISI5008OB0One Piece O-Ball Dental Implant: 5.0mm Diameter X 8mm length
D785ISI4016OB0One Piece O-Ball Dental Implant: 4.0mm Diameter X 16mm length
D785ISI4014OB0One Piece O-Ball Dental Implant: 4.0mm Diameter X 14mm length
D785ISI4012OB0One Piece O-Ball Dental Implant: 4.0mm Diameter X 12mm length
D785ISI4010OB0One Piece O-Ball Dental Implant: 4.0mm Diameter X 10mm Length
D785ISI4008OB0One Piece O-Ball Dental Implant: 4.0mm Diameter X 8mm length
D785ISI32516OB0One Piece O-Ball Dental Implant: 3.25mm Diameter X 16mm Length
D785ISI32514OB0One Piece O-Ball Dental Implant: 3.25mm Diameter X 14mm Length
D785ISI32512OB0One Piece O-Ball Dental Implant: 3.25mm Diameter X 12mm Length
D785ISI32510OB0One Piece O-Ball Dental Implant: 3.25mm Diameter X 10mm Length
D785ISI32508OB0One Piece O-Ball Dental Implant: 3.25mm Diameter X 8mm Length

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