simplyCrown&Bridge RePlant® 6043-23K

GUDID 10841307119043

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID10841307119043
NIH Device Record Key43214174-7cda-469e-b954-0c58fc9b0293
Commercial Distribution StatusIn Commercial Distribution
Brand NamesimplyCrown&Bridge RePlant®
Version Model Number6043-23K
Catalog Number6043-23K
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 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 Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307119043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307119043]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-16

On-Brand Devices [simplyCrown&Bridge RePlant®]

108413071191046060-23K
108413071190986060-22K
108413071190816060-21K
108413071190746050-23K
108413071190676050-22K
108413071190506050-21K
108413071190436043-23K
108413071190366043-22K
108413071190296043-21K
108413071190126035-23K
108413071190056035-22K
108413071189926035-21K

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