OneQ Smart KIT

GUDID 08806169145499

Dental Implant Instrument KIT/ OneQ Smart KIT

DENTIS CO. ,LTD

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

[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

• 08800313230642 - SQ AXEL Countersink: 2026-03-19 SQ AXEL Countersink (DSACS38)
• 08800313230659 - SQ AXEL Countersink: 2026-03-19 SQ AXEL Countersink (DSACS42)
• 08800313230666 - SQ AXEL Countersink: 2026-03-19 SQ AXEL Countersink (DSACS46)
• 08800313236361 - SQ Step Drill: 2026-03-19 SQ Step Drill (DSQSTD2820)
• 08800313230819 - SQ-SL AXEL Fixture: 2026-03-17 SQ-SL AXEL Fixture (DSAFM3808)
• 08800313230826 - SQ-SL AXEL Fixture: 2026-03-17 SQ-SL AXEL Fixture (DSAFM4208)
• 08800313230833 - SQ-SL AXEL Fixture: 2026-03-17 SQ-SL AXEL Fixture (DSAFM3809)
• 08800313230840 - SQ-SL AXEL Fixture: 2026-03-17 SQ-SL AXEL Fixture (DSAFM3810)