Dental T-Shaper

GUDID 08800070233610

Izenimplant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800070233610
NIH Device Record Key1621c373-dbf4-4cd3-be0a-405cf01e60b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDental T-Shaper
Version Model NumberDTSD18
Company DUNS694625347
Company NameIzenimplant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800070233610 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


[08800070233610]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-19
Device Publish Date2023-12-11

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08800070220177 - Ti Link Abutment2024-01-29
08800070220184 - Ti Link Abutment2024-01-29
08800070220191 - Ti Link Abutment2024-01-29
08800070220207 - Ti Link Abutment2024-01-29
08800070220214 - Ti Link Abutment2024-01-29
08800070220221 - Ti Link Abutment2024-01-29

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