i-Clean Angled Abutment

GUDID 08806169165800

i-Clean Angled Abutment (DIAA15N)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169165800
• NIH Device Record Key: 454c49e8-424b-464f-9383-a9bd6b56f549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Angled Abutment
• Version Model Number: DIAA15N
• 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	08806169165800 [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

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

Moist Heat or Steam Sterilization

[08806169165800]

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 Angled Abutment]

• 08806169166401: Dental Implant Abutment / i-Clean Angled Abutment / DIAA25S
• 08806169166395: Dental Implant Abutment / i-Clean Angled Abutment / DIAA15S
• 08806169165855: i-Clean Angled Abutment (DIAAW25N)
• 08806169165848: i-Clean Angled Abutment (DIAAW15N)
• 08806169165831: i-Clean Angled Abutment (DIAAW25)
• 08806169165824: i-Clean Angled Abutment (DIAAW15)
• 08806169165817: i-Clean Angled Abutment (DIAA25N)
• 08806169165800: i-Clean Angled Abutment (DIAA15N)
• 08806169106216: i-Clean Angled Abutment (DIAAW25NS)
• 08806169106209: i-Clean Angled Abutment (DIAAW15NS)
• 08806169106193: i-Clean Angled Abutment (DIAAW25S)
• 08806169106186: i-Clean Angled Abutment (DIAAW15S)
• 08806169100573: i-Clean Angled Abutment (DIAA25NS)
• 08806169100436: i-Clean Angled Abutment (DIAA15NS)