One Piece Crown & Bridge Dental Implant ISI 5008 CB

GUDID D785ISI5008CB0

One Piece Crown & Bridge Dental Implant: 5.0mm Diameter X 8mm Length

OCO BIOMEDICAL INC

Screw endosteal dental implant, one-piece
Primary Device IDD785ISI5008CB0
NIH Device Record Key7d5a2d74-2ce9-420d-aedb-9c3e9b87c79e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne Piece Crown & Bridge Dental Implant
Version Model NumberCrown & Bridge
Catalog NumberISI 5008 CB
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
HIBCCD785ISI5008CB0 [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 Crown & Bridge Dental Implant]

D785ISI5016CB0One Piece Crown & Bridge Dental Implant: 5.0mm Diameter X 16mm Length
D785ISI5014CB0One Piece Crown & Bridge Dental Implant: 5.0mm Diameter X 14mm Length
D785ISI5012CB0One Piece Crown & Bridge Dental Implant: 5.0mm Diameter X 12mm length
D785ISI5010CB0One Piece Crown & Bridge Dental Implant: 5.0mm Diameter X 10mm Length
D785ISI5008CB0One Piece Crown & Bridge Dental Implant: 5.0mm Diameter X 8mm Length
D785ISI4016CB0One Piece Crown & Bridge Dental Implant: 4.0mm Diameter X 16mm Length
D785ISI4014CB0One Piece Crown & Bridge Dental Implant: 4.0mm Diameter X 14mm Length
D785ISI4012CB0One Piece Crown & Bridge Dental Implant: 4.0mm Diameter X 12mm Length
D785ISI4010CB0One Piece Crown & Bridge Dental Implant: 4.0mm Diameter X 10 Length
D785ISI4008CB0One Piece Crown & Bridge Dental Implant: 4.0mm Diameter X 8mm Length
D785ISI32516CB0One Piece Crown & Bridge Dental Implant: 3.25mm Diameter X 16mm length
D785ISI32514CB0One Piece Crown & Bridge Dental Implant: 3.25mm Diameter X 14mm Length
D785ISI32512CB0One Piece Crown & Bridge Dental Implant: 3.25mm Diameter X 12mm Length
D785ISI32510CB0One piece Crown & Bridge Dental Implant: 3.25mm Diameter X 10mm Length
D785ISI32508CB0One Piece Crown & Bridge Dental Implant: 3.25mm Diameter X 8mm length

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