i-Clean CCM UCLA Abutment

GUDID 08806169190628

i-Clean CCM UCLA Abutment (DICUA65O)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169190628
• NIH Device Record Key: 7e855932-e4a9-432a-b2e7-361db8259142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean CCM UCLA Abutment
• Version Model Number: DICUA65O
• 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	08806169190628 [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

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

Moist Heat or Steam Sterilization

[08806169190628]

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 CCM UCLA Abutment]

• 08806169190789: i-Clean CCM UCLA Abutment (DICUA65OS)
• 08806169190772: i-Clean CCM UCLA Abutment (DICUA60OS)
• 08806169190765: i-Clean CCM UCLA Abutment (DICUA48OS)
• 08806169190659: i-Clean CCM UCLA Abutment (DICUA65N)
• 08806169190642: i-Clean CCM UCLA Abutment (DICUA60N)
• 08806169190635: i-Clean CCM UCLA Abutment (DICUA48N)
• 08806169190628: i-Clean CCM UCLA Abutment (DICUA65O)
• 08806169190611: i-Clean CCM UCLA Abutment (DICUA60O)
• 08806169190604: i-Clean CCM UCLA Abutment (DICUA48O)
• 08806169107510: i-Clean CCM UCLA Abutment (DICUA65NS)
• 08806169107497: i-Clean CCM UCLA Abutment (DICUA60NS)
• 08806169107473: i-Clean CCM UCLA Abutment (DICUA48NS)