Small Diameter Dental Implant SDI 2512 CB

GUDID D785SDI2512CB0

Small Diameter Dental Implant: 2.5mm Diameter X 12mm Length

OCO BIOMEDICAL INC

Screw endosteal dental implant, one-piece
Primary Device IDD785SDI2512CB0
NIH Device Record Keyb43df135-9eb6-41b4-bc58-9ee3e355e449
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmall Diameter Dental Implant
Version Model NumberSDI
Catalog NumberSDI 2512 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
HIBCCD785SDI2512CB0 [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 Date2016-03-15

On-Brand Devices [Small Diameter Dental Implant]

D785SDI2916OB0Small Diameter Dental Implant: 2.9mm Diameter X 16mm length
D785SDI2916CB0Small Diameter Dental Implant: 2.9mm Diameter X 16mm Length
D785SDI2914OB0Small Diameter Dental Implant: 2.9mm Diameter X 14mm Length
D785SDI2914CB0Small Diameter Dental Implant: 2.9mm Diameter X 14mm Length
D785SDI2912OB0Small Diameter Dental Implant: 2.9mm Diameter X 12mm Length
D785SDI2912CB0Small Diameter Dental Implant: 2.9mm Diameter X 12mm Length
D785SDI2910OB0Small Diameter Dental Implant: 2.9mm Diameter X 10mm Length
D785SDI2910CB0Small Diameter Dental Implant: 2.9mm Diameter X 10mm Length
D785SDI2908OB0Small Diameter Dental Implant: 2.9mm Diameter X 8mm Length
D785SDI2908CB0Small Diameter Dental Implant: 2.9mm Diameter X 8mm Length
D785SDI2516OB0Small Diameter Dental Implant : 2.5mm Diameter X 16mm Length
D785SDI2516CB0Small Diameter Dental Implant: 2.5mm Diameter X 16mm Length
D785SDI2514OB0Small Diameter Dental Implant: 2.5mm Diameter X 14mm Length
D785SDI2514CB0Small Diameter Dental Implant: 2.5mm Diameter X 14mm Length
D785SDI2512OB0Small Diameter Dental Implant: 2.5mm Diameter X 12mm Length
D785SDI2512CB0Small Diameter Dental Implant: 2.5mm Diameter X 12mm Length
D785SDI2510OB0Small Diameter Dental Implant: 2.5mm Diameter X 10mm Length
D785SDI2510CB0Small Diameter Dental Implant: 2.5mm Diameter X 10mm Length
D785SDI2216OB0Small Diameter Dental Implant: 2.2mm Diameter X 16mm Length
D785SDI2216CB0Small Diameter Dental Implant: 2.2mm Diameter X 16mm Length
D785SDI2214OB0Small Diameter Dental Implant: 2.2mm Diameter X 14mm Length
D785SDI2214CB0Small Diameter Dental Implant: 2.2mm Diameter X 14mm Length
D785SDI2212OB0Small Diameter Dental Implant: 2.2mm Diameter X 12mm length
D785SDI2212CB0Small Diameter Dental Implant: 2.2mm Diameter X 12mm Length
D785SDI2210OB0Small Diameter Dental Implant: 2.2mm Diameter X 10mm Length
D785SDI2210CB0Small Diameter Implant: 2.2mm Diameter X 10mm Length

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