i-Clean Solid Abutment Healing Cap

GUDID 08806169100719

Dental Implant System / i-Clean Healing Cap D5.5mm X L6.5mm / Solid

DENTIS CO., LTD.

Multi-purpose surgical mesh, metallic

• Primary Device ID: 08806169100719
• NIH Device Record Key: 0c8460e6-1c3c-43bc-855e-48ed64e7f2ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Solid Abutment Healing Cap
• Version Model Number: DISHC40
• 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: 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	08806169100719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

[08806169100719]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-01
• Device Publish Date: 2015-08-21

On-Brand Devices [i-Clean Solid Abutment Healing Cap]

• 08806169100733: Dental Implant System / i-Clean Healing Cap D5.5mm X L9.5mm / Solid
• 08806169100726: Dental Implant System / i-Clean Healing Cap D5.5mm X L8.0mm / Solid
• 08806169100719: Dental Implant System / i-Clean Healing Cap D5.5mm X L6.5mm / Solid
• 08806169105073: Dental Implant System / i-Clean Healing Cap D5.4mm X L4.7mm / Solid