UMA TitaniumTemporary Non-Hex Cylinder 11-000352

GUDID 10841307118039

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID10841307118039
NIH Device Record Key310911de-acaf-46f5-8f96-80537f4ea4a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameUMA TitaniumTemporary Non-Hex Cylinder
Version Model Number11-000352
Catalog Number11-000352
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 Identifiers

Device Issuing AgencyDevice ID
GS110841307118039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307118039]

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

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10841307111641 - Legacy™ Plastic Engaging Temporary Abutment2024-12-23
10841307111696 - Legacy™ Plastic Temporary Abutment2024-12-23
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10841307103592 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD
10841307103608 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD
10841307103615 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD

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