i-Clean Cover Screw

GUDID 08806169100122

Dental Implant System / i-Clean Cover Screw D5.2mm X L6.4mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806169100122
• NIH Device Record Key: 4466a534-ed92-4956-9ef2-db79ceb48b78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Cover Screw
• Version Model Number: DICS1
• 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	08806169100122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-08
• Device Publish Date: 2015-07-30

On-Brand Devices [i-Clean Cover Screw]

• 08806169100252: Dental Implant System / i-Clean Cover Screw D6.4mm X L6.4mm
• 08806169100122: Dental Implant System / i-Clean Cover Screw D5.2mm X L6.4mm
• 08806169105035: Dental Implant System / i-Clean Cover Screw D7.4mm X L6.4mm
• 08806169105028: Dental Implant System / i-Clean Cover Screw D7.0mm X L6.4mm