simply Legacy™2 Implant 825213U

GUDID 10841307107521

5.2mmD x 13mmL, 4.5mmD Platform

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system
Primary Device ID10841307107521
NIH Device Record Key667876ee-0a54-4ec2-a4d7-f5386bfe4161
Commercial Distribution StatusIn Commercial Distribution
Brand Namesimply Legacy™2 Implant
Version Model Number825213U
Catalog Number825213U
Company DUNS868856969
Company NameIMPLANT DIRECT SYBRON MANUFACTURING LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110841307107521 [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 Date2020-08-10
Device Publish Date2015-09-14

On-Brand Devices [simply Legacy™2 Implant]

108413071076207.0mmD x 13mmL, 5.7mmD Platform
108413071076137.0mmD x 11.5mmL, 5.7mmD Platform
108413071076067.0mmD x 10mmL, 5.7mmD Platform
108413071075907.0mmD x 8mmL, 5.7mmD Platform
108413071075835.7mmD x 16mmL, 5.7mmD Platform
108413071075765.7mmD x 13mmL, 5.7mmD Platform
108413071075695.7mmD x 11.5mmL, 5.7mmD Platform
108413071075525.7mmD x 10mmL, 5.7mmD Platform
108413071075455.7mmD x 8mmL, 5.7mmD Platform
108413071075385.2mmD x 16mmL, 4.5mmD Platform
108413071075215.2mmD x 13mmL, 4.5mmD Platform
108413071075145.2mmD x 11.5mmL, 4.5mmD Platform
108413071075075.2mmD x 10mmL, 4.5mmD Platform
108413071074915.2mmD x 8mmL, 4.5mmD Platform
108413071074844.7mmD x 16mmL, 4.5mmD Platform
108413071074774.7mmD x 13mmL, 4.5mmD Platform
108413071074604.7mmD x 11.5mmL, 4.5mmD Platform
108413071074534.7mmD x 10mmL, 4.5mmD Platform
108413071074464.7mmD x 8mmL, 4.5mmD Platform
108413071074394.2mmD x 16mmL, 3.5mmD Platform
108413071074224.2mmD x 13mmL, 3.5mmD Platform
108413071074154.2mmD x 11.5mmL, 3.5mmD Platform
108413071074084.2mmD x 10mmL, 3.5mmD Platform
108413071073924.2mmD x 8mmL, 3.5mmD Platform
108413071073853.7mmD x 16mmL, 3.5mmD Platform
108413071073783.7mmD x 13mmL, 3.5mmD Platform
108413071073613.7mmD x 11.5mmL, 3.5mmD Platform
108413071073543.7mmD x 10mmL, 3.5mmD Platform
108413071073473.7mmD x 8mmL, 3.5mmD Platform
108413071073303.2mmD x 16mmL, 3.0mmD Platform
108413071073233.2mmD x 13mmL, 3.0mmD Platform
108413071073163.2mmD x 11.5mmL, 3.0mmD Platform
108413071073093.2mmD x 10mmL, 3.0mmD Platform
108413071072933.2mmD x 8mmL, 3.0mmD Platform
108413071072867.0mmD x 6mmL, 5.7mmD Platform
108413071072795.7mmD x 6mmL, 5.7mmD Platform
108413071072625.2mmD x 6mmL, 4.5mmD Platform
108413071072554.7mmD x 6mmL, 4.5mmD Platform
108413071072484.2mmD x 6mmL, 3.5mmD Platform
108413071072313.7mmD x 6mmL, 3.5mmD Platform
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