UF(II) Implant System SSCA 55405N(II)

GUDID 08800049429129

DIO Corporation

Dental implant suprastructure, permanent, preformed

Primary Device ID	08800049429129
NIH Device Record Key	418ad317-5893-476c-821d-fb330b7ca8b3
Commercial Distribution Status	In Commercial Distribution
Brand Name	UF(II) Implant System
Version Model Number	SSCA 55405N(II)
Catalog Number	SSCA 55405N(II)
Company DUNS	631085206
Company Name	DIO Corporation
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800049429129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170608

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous