Scan Healing Abutment Screw

GUDID 08800055793313

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800055793313
• NIH Device Record Key: 4184e5af-89ce-412a-8602-0e1cdbb77e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scan Healing Abutment Screw
• Version Model Number: HAS-S16R
• 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	08800055793313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230725

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

[08800055793313]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [Scan Healing Abutment Screw]

• 08800055793320: HAS-S18R
• 08800055793313: HAS-S16R
• 08800055793306: HAS-S14R
• 08800055793290: HAS-S12R
• 08800055793283: HAS-S10R
• 08809917605993: HAS-S18R
• 08809917605986: HAS-S16R
• 08809917605979: HAS-S14R
• 08809917605962: HAS-S12R
• 08809917605955: HAS-S10R
• 08809917605948: HAS-S19M
• 08809917605931: HAS-S17M
• 08809917605924: HAS-S15M
• 08809917605917: HAS-S13M
• 08809917605900: HAS-S11M