Healing Abutment

GUDID 08809917604286

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08809917604286
• NIH Device Record Key: fb6c9f8b-b840-4c6a-91ee-c55f62b2f07c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Abutment
• Version Model Number: HA5504GR
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	08809917604286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222131

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

[08809917604286]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-06
• Device Publish Date: 2023-03-29

On-Brand Devices [Healing Abutment]

• 08809917604309: HA5506GR
• 08809917604293: HA5505GR
• 08809917604286: HA5504GR
• 08809917604279: HA5503GR
• 08809917604262: HA5502GR
• 08809917604255: HA4510GR
• 08809917604248: HA4509GR
• 08809917604231: HA4508GR
• 08809917604224: HA4507GR
• 08809917604217: HA4506GR
• 08809917604200: HA4505GR
• 08809917604194: HA4504GR
• 08809917604187: HA4503GR
• 08809917604170: HA4502GR
• 08809917604163: HA4010GR
• 08809917604156: HA4009GR
• 08809917604149: HA4008GR
• 08809917604132: HA4007GR
• 08809917604125: HA4006GR
• 08809917604118: HA4005GR
• 08809917604101: HA4004GR
• 08809917604095: HA4003GR
• 08809917604088: HA4002GR
• 08809917604521: HA7510GR
• 08809917604514: HA7509GR
• 08809917604507: HA7508GR
• 08809917604491: HA7507GR
• 08809917604484: HA7506GR
• 08809917604477: HA7505GR
• 08809917604460: HA7504GR
• 08809917604453: HA7503GR
• 08809917604446: HA7502GR
• 08809917604439: HA6510GR
• 08809917604422: HA6509GR
• 08809917604415: HA6508GR
• 08809917604408: HA6507GR
• 08809917604392: HA6506GR
• 08809917604385: HA6505GR
• 08809917604378: HA6504GR
• 08809917604361: HA6503GR
• 08809917604354: HA6502GR
• 08809917604347: HA5510GR
• 08809917604330: HA5509GR
• 08809917604323: HA5508GR
• 08809917604316: HA5507GR
• 08809917603470: HA4004R
• 08809917603463: HA4003R
• 08809917603456: HA4002R
• 08809917603449: HA4510M
• 08809917603432: HA4509M