38320

GUDID 07332747102871

Trefoil™ Implant CC RP 5.0x11.5+4.5mm

Nobel Biocare AB

Screw endosteal dental implant, two-piece
Primary Device ID07332747102871
NIH Device Record Key43d61fa1-e5d3-483a-b921-2acab429c6a1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number38320
Catalog Number38320
Company DUNS353939929
Company NameNobel Biocare AB
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Height4.5 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747102871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-31
Device Publish Date2016-05-03

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