OneQ-SL Implant DISOF4847103s

GUDID 08806169126092

4.8 platform Ø4.7x10mm

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169126092
• NIH Device Record Key: abf7250d-2631-460b-88b8-0cb781ee978b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneQ-SL Implant
• Version Model Number: DISOF4847103
• Catalog Number: DISOF4847103s
• Company DUNS: 694721181
• 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	08806169126092 [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: 2020-07-27
• Device Publish Date: 2016-02-03

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