i-Clean Octa CCM Cylinder

GUDID 08806169190710

i-Clean Octa CCM Cylinder (DIOCC60O)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169190710
• NIH Device Record Key: f3be8ea5-737d-4e78-8057-cfdd98209369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Octa CCM Cylinder
• Version Model Number: DIOCC60O
• 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: 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	08806169190710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230307

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

[08806169190710]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-27
• Device Publish Date: 2023-07-19

On-Brand Devices [i-Clean Octa CCM Cylinder]

• 08806169190819: i-Clean Octa CCM Cylinder (DIOCC65OS)
• 08806169190802: i-Clean Octa CCM Cylinder (DIOCC60OS)
• 08806169190796: i-Clean Octa CCM Cylinder (DIOCC48OS)
• 08806169190758: i-Clean Octa CCM Cylinder (DIOCC65N)
• 08806169190741: i-Clean Octa CCM Cylinder (DIOCC60N)
• 08806169190734: i-Clean Octa CCM Cylinder (DIOCC48N)
• 08806169190727: i-Clean Octa CCM Cylinder (DIOCC65O)
• 08806169190710: i-Clean Octa CCM Cylinder (DIOCC60O)
• 08806169190703: i-Clean Octa CCM Cylinder (DIOCC48O)
• 08806169112149: i-Clean Octa CCM Cylinder (DIOCC65NS)
• 08806169112132: i-Clean Octa CCM Cylinder (DIOCC60NS)
• 08806169112125: i-Clean Octa CCM Cylinder (DIOCC48NS)