i-Clean Healing Cap

GUDID 08806169131973

Dental Implant System / i-Clean Healing Cap D7.0mm X L9.5mm / Solid

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806169131973
• NIH Device Record Key: 881fe6b4-a504-4db7-8051-b6e264c804aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Healing Cap
• Version Model Number: DISWHC70
• 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	08806169131973 [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

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

[08806169131973]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-30
• Device Publish Date: 2019-05-22

On-Brand Devices [i-Clean Healing Cap]

• 08806169131973: Dental Implant System / i-Clean Healing Cap D7.0mm X L9.5mm / Solid
• 08806169131966: Dental Implant System / i-Clean Healing Cap D7.0mm X L8.0mm / Solid
• 08806169131959: Dental Implant System / i-Clean Healing Cap D7.0mm X L6.5mm / Solid