Bone Level UCLA 6057 UCLA E (DEL)

GUDID D78560578UCLAEDEL0

8mm UCLA E (DEL) 8mm Diameter Engaging Delrin Base

OCO BIOMEDICAL INC

Dental implant system
Primary Device IDD78560578UCLAEDEL0
NIH Device Record Key66930a73-18c0-4a47-82ad-af5d97ea18ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Level UCLA
Version Model Number8mm UCLA E (DEL)
Catalog Number6057 UCLA E (DEL)
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 Datefalse
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
HIBCCD78560578UCLAEDEL0 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D78560578UCLAEDEL0]

Moist Heat or Steam Sterilization


[D78560578UCLAEDEL0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-20

On-Brand Devices [Bone Level UCLA]

D78560UCLANE06mm UCLA 6mm Diameter Non-Engaging Delrin Ti Base
D78560UCLAE06mm UCLA 6mm Diameter Engaging Delrin Ti Base
D7856057UCLANEDEL06mm UCLA NE (DEL) 6mm Diameter Non-Engaging Delrin Base
D7856057UCLANE07mm UCLA 7mm Diameter Non-Engaging Delrin Ti Base
D7856057UCLAEDEL06mm UCLA E (DEL) 6mm Diameter Engaging Delrin Base
D7856057UCLAE07mm UCLA 7mm Diameter Engaging Delrin Ti Base
D78560578UCLANEDEL08mm UCLA NE (DEL) 8mm Diameter Non-Engaging Delrin Base
D78560578UCLANE08mm UCLA 8mm Diameter Non-Engaging Delrin Ti Base
D78560578UCLAEDEL08mm UCLA E (DEL) 8mm Diameter Engaging Delrin Base
D78560578UCLAE08mm UCLA 8mm Diameter Engaging Delrin Ti Base
D78560577UCLANEDEL07mm UCLA NE (DEL) 7mm Diameter Non-Engaging Delrin Base
D78560577UCLAEDEL07mm UCLA E (DEL) 7mm Diameter Engaging Delrin Base
D78550UCLANE05mm UCLA 5mm Diameter Non-Engaging Delrin Ti Base
D78550UCLAE05mm UCLA 5mm Diameter Engaging Delrin Ti Base
D7855045UCLANEDEL05mm UCLA NE (DEL) 5mm Diameter Non-Engaging Delrin Base
D7855045UCLAEDEL05mm UCLA E (DEL) 5mm Diameter Engaging Delrin Base
D78540UCLANE04mm UCLA 4mm Diameter Non-Engaging Delrin Ti Base
D78540UCLAE04mm UCLA 4mm Diameter Engaging Delrin Ti Base
D7854035UCLANEDEL04mm UCLA NE (DEL) 4mm Diameter Non-Engaging Delrin Base
D7854035UCLAEDEL04mm UCLA E (DEL) 4mm Diameter Engaging Delrin Base
D785325UCLANE03.25mm UCLA 3.25mm Diameter Non-Engaging Delrin Ti Base
D785325UCLAE03.25 UCLA 3.25mm Diameter Engaging Delrin Ti Base
D78532530UCLANEDEL03.25mm UCLA NE (DEL) 3.25mm Diameter Non-Engaging Delrin Base

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