i-Clean Closing Screw

GUDID 08806169100139

Dental Implant System / i-Clean Closing Screw D3.5mm X L5.5mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806169100139
• NIH Device Record Key: dd2a3081-7d34-4e59-8bb8-16915144d96f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Closing Screw
• Version Model Number: DICS3
• 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	08806169100139 [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 Closing Screw]

• 08806169100139: Dental Implant System / i-Clean Closing Screw D3.5mm X L5.5mm
• 08800053007818: Dental Implant System / i-Clean Closing Screw D4.3mm X L5.8mm