Dalla Bona Male 5.0mm - Branemark RP 4.1 Compatible 44-430053

GUDID 10841307118398

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID10841307118398
NIH Device Record Keybed9d24d-2b2b-4279-aa0e-56133c871f81
Commercial Distribution StatusIn Commercial Distribution
Brand NameDalla Bona Male 5.0mm - Branemark RP 4.1 Compatible
Version Model Number44-430053
Catalog Number44-430053
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
GS110841307118398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307118398]

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

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

10841307131014 - DIRECTguide™ Guided Surgery Kit - Empty2024-05-28
10841307131021 - DIRECTguide™ Guided Surgery Kit - Legacy2024-05-28
10841307131038 - DIRECTguide™ Guided Surgery Kit - Conical2024-05-28
10841307131045 - DIRECTguide™ Guided Step Drill 2024-05-28
10841307131052 - DIRECTguide™ Guided Step Drill 2024-05-28
10841307131069 - DIRECTguide™ Guided Step Drill 2024-05-28
10841307131076 - DIRECTguide™ Guided Step Drill 2024-05-28
10841307131083 - DIRECTguide™ Guided Step Drill 2024-05-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.