Guide Wheel Initial Drill

GUDID 08800053023054

Dental Implant Instrument / Guide Wheel Initial Drill

DENTIS CO. ,LTD

Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material
Primary Device ID08800053023054
NIH Device Record Key3b12ea7e-5ef2-479d-8a99-efc243610d2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuide Wheel Initial Drill
Version Model NumberDGWID20
Company DUNS694721181
Company NameDENTIS 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
GS108800053023054 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


[08800053023054]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by DENTIS CO. ,LTD

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08800053082815 - MESHEET075-R2024-03-13
08800053042093 - DENOPS2024-01-31 DC : 3.7 V, 550mh(Battery)
08800053045032 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
08800053045049 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
08800053045056 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA

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