Inosys

GUDID D124PMRBL0

Primus Blank 10mm Regular

Creo Dent Hudson Valley, Inc.

Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made Dental implant suprastructure, permanent, custom-made

Primary Device ID	D124PMRBL0
NIH Device Record Key	503bb0db-c9f9-423d-a7de-a597e153554f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Inosys
Version Model Number	PMRBL
Company DUNS	071221112
Company Name	Creo Dent Hudson Valley, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D124PMRBL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160436

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous