O-Ring Abutment Retainer

GUDID 08800053000055

O-Ring Abutment Retainer (DORS = DOR(K073486) + DOAO100(D079308) + DOAO400(K230126) + DOAO800(K230126))

DENTIS CO. ,LTD

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Primary Device ID	08800053000055
NIH Device Record Key	47c9593f-bf41-4f0f-88ce-7b47d26dd520
Commercial Distribution Status	In Commercial Distribution
Brand Name	O-Ring Abutment Retainer
Version Model Number	DORS
Company DUNS	694721181
Company Name	DENTIS CO. ,LTD
Device Count	1
DM Exempt	false
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	false
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800053000055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230126

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous