IMZ 3.3 Healing Cap 6mm 56-302160

GUDID 10841307122418

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID10841307122418
NIH Device Record Keydebd66aa-2f6f-4462-bdf6-95a12498f666
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMZ 3.3 Healing Cap 6mm
Version Model Number56-302160
Catalog Number56-302160
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307122418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307122418]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-08-31

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