OneQ-SL Implant

GUDID 08806169126528

Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L7.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169126528
• NIH Device Record Key: e500a393-15c1-4f2d-abc7-1bbe875e4b77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneQ-SL Implant
• Version Model Number: DISOF6552072
• Company DUNS: 688204158
• Company Name: DENTIS CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	08806169126528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142313

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-02-11

On-Brand Devices [OneQ-SL Implant]

• 08806169126528: Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L7.0mm
• 08806169126337: Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L8.0mm