MILLING BLANK 5045 MB

GUDID D7855045MB0

5.0MM MILLING BLANK (4.5MM PLATFORM)

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed
Primary Device IDD7855045MB0
NIH Device Record Key2ac72ead-2692-49aa-bc24-0f2b465fd522
Commercial Distribution StatusIn Commercial Distribution
Brand NameMILLING BLANK
Version Model Number5.0MM MILLING BLANK 4.5MM PLATFORM
Catalog Number5045 MB
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7855045MB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


[D7855045MB0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-20
Device Publish Date2024-03-12

On-Brand Devices [MILLING BLANK]

D7855045MB05.0MM MILLING BLANK (4.5MM PLATFORM)
D7854035MB04.0MM MILLING BLANK (3.5MM PLATFORM)
D78532530MB03.25MM MILLING BLANK (3.0MM PLATFORM)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.