301123

GUDID 07332747166835

On1 Universal Abutment Engaging RP 0.3 mm US

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed

Primary Device ID	07332747166835
NIH Device Record Key	8541e057-096e-4b9d-9f2b-8cee12c00b41
Commercial Distribution Status	In Commercial Distribution
Version Model Number	301123
Catalog Number	301123
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	true
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	true
OTC Over-The-Counter	false

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

Device Dimensions

Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter
Height	0.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747166835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181869

FDA Product Code

PNP	Dental abutment design software for dental laboratory