PureSet PUR0501

GUDID 07332747167160

Prosthetic PureSet Plate

Nobel Biocare AB

Instrument tray

Primary Device ID	07332747167160
NIH Device Record Key	fa2124ba-33a5-4ec3-88cb-4317fc3444ec
Commercial Distribution Status	In Commercial Distribution
Brand Name	PureSet
Version Model Number	PUR0501
Catalog Number	PUR0501
Company DUNS	353939929
Company Name	Nobel Biocare AB
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	false
Lot Batch	true
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	true

Customer Support Contacts

Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com

Device Dimensions

Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter
Height	2 Millimeter
Length	110 Millimeter
Width	59.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747167160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191475

FDA Product Code

KCT	Sterilization wrap containers, trays, cassettes & other accessories