Customized Abutment

GUDID 08800055717654

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800055717654
• NIH Device Record Key: 2ec1d46b-22d4-491e-9a83-dfdf0fc146e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Customized Abutment
• Version Model Number: CSHE002
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800055717654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223634

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

[08800055717654]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-17
• Device Publish Date: 2023-05-09

On-Brand Devices [Customized Abutment]

• 08800055716749: CAH10R
• 08809924584557: CIHE020S
• 08809924584540: CIHE019S
• 08809924584533: CIHE016S
• 08809924584526: CIHE015S
• 08809924584519: CIHE012S
• 08809924584502: CIHE011S
• 08809924584496: CIHE008S
• 08809924584489: CIHE007S
• 08809924584472: CIHE006S
• 08809924584465: CIHE005S
• 08809924584458: CIHE004S
• 08809924584441: CIHE003S
• 08809924584434: CAH14RS
• 08809924584427: CAH10RS
• 08800055777320: CAH14RP
• 08800055777313: CAH10RP
• 08800055762036: CIHE020P
• 08800055762029: CIHE019P
• 08800055761992: CIHE016P
• 08800055761985: CIHE015P
• 08800055761954: CIHE012P
• 08800055761947: CIHE011P
• 08800055761916: CIHE008P
• 08800055761909: CIHE007P
• 08800055761893: CIHE006P
• 08800055761886: CIHE005P
• 08800055761879: CIHE004P
• 08800055761862: CIHE003P
• 08800055717739: CSHE010
• 08800055717715: CSHE008
• 08800055717678: CSHE004
• 08800055717661: CSHE003
• 08800055717654: CSHE002
• 08800055716756: CAH14R
• 08800055715575: CIHE020
• 08800055715568: CIHE019
• 08800055715537: CIHE016
• 08800055715520: CIHE015
• 08800055715490: CIHE012
• 08800055715483: CIHE011
• 08800055715452: CIHE008
• 08800055715445: CIHE007
• 08800055715438: CIHE006
• 08800055715421: CIHE005
• 08800055715414: CIHE004
• 08800055715407: CIHE003
• 08800055769417: CISQ008P
• 08800055769400: CISQ007P
• 08800055769394: CISQ006P