OneQ Smart KIT

GUDID 08806169145499

Dental Implant Instrument KIT/ OneQ Smart KIT

DENTIS CO. ,LTD

Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit Dental implant kit

• Primary Device ID: 08806169145499
• NIH Device Record Key: 445a75c7-ee76-489e-8f1c-db989711cb32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneQ Smart KIT
• Version Model Number: DIOSK
• Company DUNS: 694721181
• Company Name: DENTIS CO. ,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169145499 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

[08806169145499]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-10
• Device Publish Date: 2021-06-02

Devices Manufactured by DENTIS CO. ,LTD

• 08800053005173 - Marking drill: 2021-06-11 Dental Implant Instrument / Marking drill
• 08800053005487 - s-Clean HI Bite Coping: 2021-06-11 Dental Implant Instrument / s-Clean HI Bite Coping
• 08800053005494 - s-Clean HI Bite Coping: 2021-06-11 Dental Implant Instrument / s-Clean HI Bite Coping
• 08800053005500 - s-Clean HI Bite Coping: 2021-06-11 Dental Implant Instrument / s-Clean HI Bite Coping
• 08800053006439 - Carbide Bur: 2021-06-11 Dental Implant Instrument / Carbide Bur
• 08800053006446 - Carbide Bur: 2021-06-11 Dental Implant Instrument / Carbide Bur
• 08800053006989 - SQ Step Drill: 2021-06-11 Dental Implant Instrument / SQ Step Drill
• 08800053006996 - SQ Step Drill: 2021-06-11 Dental Implant Instrument / SQ Step Drill