NobelZygoma™ 38276

GUDID 07332747098761

NobelZygoma™ 0° 35mm

Nobel Biocare AB

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

Primary Device ID	07332747098761
NIH Device Record Key	368e6603-eeb5-42ec-969d-ab71bf615ee4
Commercial Distribution Status	In Commercial Distribution
Brand Name	NobelZygoma™
Version Model Number	38276
Catalog Number	38276
Company DUNS	353939929
Company Name	Nobel Biocare AB
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	false
Manufacturing Date	false
Expiration Date	true
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
Phone	+1(800)322-5001
Email	us.customerservice@nobelbiocare.com

Device Dimensions

Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter
Length	35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747098761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161598

FDA Product Code

DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-05-31
Device Publish Date	2017-05-17

On-Brand Devices [NobelZygoma™]

07332747112405	NobelZygoma™ 0° Angled Multi-unit Abutment Screw
07332747102826	NobelZygoma™ 45° 52.5mm
07332747102819	NobelZygoma™ 45° 50mm
07332747102802	NobelZygoma™ 45° 47.5mm
07332747102796	NobelZygoma™ 45° 45mm
07332747102789	NobelZygoma™ 45° 42.5mm
07332747102772	NobelZygoma™ 45° 40mm
07332747102765	NobelZygoma™ 45° 37.5mm
07332747102758	NobelZygoma™ 45° 35mm
07332747102741	NobelZygoma™ 45° 32.5mm
07332747102734	NobelZygoma™ 45° 30mm
07332747102727	NobelZygoma™ 0° 50mm
07332747102710	NobelZygoma™ 0° 47.5mm
07332747102703	NobelZygoma™ 0° 45mm
07332747098792	NobelZygoma™ 0° 42.5mm
07332747098785	NobelZygoma™ 0° 40mm
07332747098778	NobelZygoma™ 0° 37.5mm
07332747098761	NobelZygoma™ 0° 35mm
07332747098754	NobelZygoma™ 0° 30mm
07332747161632	NobelZygoma™ 45° 52.5mm
07332747161625	NobelZygoma™ 45° 50mm
07332747161618	NobelZygoma™ 45° 47.5mm
07332747161601	NobelZygoma™ 45° 45mm
07332747161595	NobelZygoma™ 45° 42.5mm
07332747161588	NobelZygoma™ 45° 40mm
07332747161571	NobelZygoma™ 45° 37.5mm
07332747161564	NobelZygoma™ 45° 35mm
07332747161557	NobelZygoma™ 45° 32.5mm
07332747161540	NobelZygoma™ 45° 30mm
07332747161533	NobelZygoma™ 0° 50mm
07332747161526	NobelZygoma™ 0° 47.5mm
07332747161519	NobelZygoma™ 0° 45mm
07332747161502	NobelZygoma™ 0° 42.5mm
07332747161496	NobelZygoma™ 0° 40mm
07332747161489	NobelZygoma™ 0° 37.5mm
07332747161472	NobelZygoma™ 0° 35mm
07332747161465	NobelZygoma™ 0° 30mm
07332747089134	NobelZygoma 0° Twist Drill 4.4mm Short
07332747089127	NobelZygoma 0° Twist Drill 4.4mm
07332747089110	NobelZygoma 0° Twist Drill 4.0mm Short
07332747089103	NobelZygoma 0° Twist Drill 4.0mm
07332747089097	NobelZygoma 0° Twist Drill 3.5mm Short
07332747089080	NobelZygoma 0° Twist Drill 3.5mm
07332747089073	NobelZygoma 0° Twist Drill 2.9mm Short
07332747089066	NobelZygoma 0° Twist Drill 2.9mm