simply Legacy™3 Implant 853713U

GUDID 10841307107774

3.7mmD x 13mmL, 3.5mmD Platform

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system
Primary Device ID10841307107774
NIH Device Record Key00e204e3-a90d-49b5-9f75-c7f12b4eca97
Commercial Distribution StatusIn Commercial Distribution
Brand Namesimply Legacy™3 Implant
Version Model Number853713U
Catalog Number853713U
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
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307107774 [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™3 Implant]

108413071080237.0mmD x 13mmL, 5.7mmD Platform
108413071080167.0mmD x 11.5mmL, 5.7mmD Platform
108413071080097.0mmD x 10mmL, 5.7mmD Platform
108413071079967.0mmD x 8mmL, 5.7mmD Platform
108413071079895.7mmD x 16mmL, 5.7mmD Platform
108413071079725.7mmD x 13mmL, 5.7mmD Platform
108413071079655.7mmD x 11.5mmL, 5.7mmD Platform
108413071079585.7mmD x 10mmL, 5.7mmD Platform
108413071079415.7mmD x 8mmL, 5.7mmD Platform
108413071079345.2mmD x 16mmL, 4.5mmD Platform
108413071079275.2mmD x 13mmL, 4.5mmD Platform
108413071079105.2mmD x 11.5mmL, 4.5mmD Platform
108413071079035.2mmD x 10mmL, 4.5mmD Platform
108413071078975.2mmD x 8mmL, 4.5mmD Platform
108413071078804.7mmD x 16mmL, 4.5mmD Platform
108413071078734.7mmD x 13mmL, 4.5mmD Platform
108413071078664.7mmD x 11.5mmL, 4.5mmD Platform
108413071078594.7mmD x 10mmL, 4.5mmD Platform
108413071078424.7mmD x 8mmL, 4.5mmD Platform
108413071078354.2mmD x 16mmL, 3.5mmD Platform
108413071078284.2mmD x 13mmL, 3.5mmD Platform
108413071078114.2mmD x 11.5mmL, 3.5mmD Platform
108413071078044.2mmD x 10mmL, 3.5mmD Platform
108413071077984.2mmD x 8mmL, 3.5mmD Platform
108413071077813.7mmD x 16mmL, 3.5mmD Platform
108413071077743.7mmD x 13mmL, 3.5mmD Platform
108413071077673.7mmD x 11.5mmL, 3.5mmD Platform
108413071077503.7mmD x 10mmL, 3.5mmD Platform
108413071077433.7mmD x 8mmL, 3.5mmD Platform
108413071077363.2mmD x 16mmL, 3.0mmD Platform
108413071077293.2mmD x 13mmL, 3.0mmD Platform
108413071077123.2mmD x 11.5mmL, 3.0mmD Platform
108413071077053.2mmD x 10mmL, 3.0mmD Platform
108413071076993.2mmD x 8mmL, 3.0mmD Platform
108413071076827.0mmD x 6mmL, 5.7mmD Platform
10841307107675Ø3.7 x 8 Platform 3.5mmD
10841307107668Ø3.7 x 8 Platform 3.5mmD
10841307107651Ø3.7 x 8 Platform 3.5mmD
10841307107644Ø3.7 x 8 Platform 3.5mmD
10841307107637Ø3.7 x 8 Platform 3.5mmD
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.