Solid Abutment

GUDID 08800039317689

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Dental implant system

• Primary Device ID: 08800039317689
• NIH Device Record Key: 07caeb4e-115a-4edc-b3e7-505b09c114ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solid Abutment
• Version Model Number: HISS6045
• Company DUNS: 631169224
• Company Name: InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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	08800039317689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140806

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

[08800039317689]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-16
• Device Publish Date: 2024-10-08

On-Brand Devices [Solid Abutment]

• 08800039302425: HISS6547
• 08800039302418: HISS6537
• 08800039302401: HISS6527
• 08800039302395: HISS6517
• 08800039302388: HISS6545
• 08800039302371: HISS6535
• 08800039302364: HISS6525
• 08800039302357: HISS6515
• 08800039302340: HISS6544
• 08800039302333: HISS6534
• 08800039302326: HISS6524
• 08800039302319: HISS6514
• 08800039302302: HISS5547
• 08800039302296: HISS5537
• 08800039302289: HISS5527
• 08800039302272: HISS5517
• 08800039302265: HISS5545
• 08800039302258: HISS5535
• 08800039302241: HISS5525
• 08800039302234: HISS5515
• 08800039302227: HISS5544
• 08800039302210: HISS5534
• 08800039302203: HISS5524
• 08800039302197: HISS5514
• 08800039302180: HISS4547
• 08800039302173: HISS4537
• 08800039302166: HISS4527
• 08800039302159: HISS4517
• 08800039302142: HISS4545
• 08800039302135: HISS4535
• 08800039302128: HISS4525
• 08800039302111: HISS4515
• 08800039302104: HISS4544
• 08800039302098: HISS4534
• 08800039302081: HISS4524
• 08800039302074: HISS4514
• 08800039302067: HISS4047
• 08800039302050: HISS4037
• 08800039302043: HISS4027
• 08800039302036: HISS4017
• 08800039302029: HISS4045
• 08800039302012: HISS4035
• 08800039302005: HISS4025
• 08800039301992: HISS4015
• 08800039301985: HISS4044
• 08800039301978: HISS4034
• 08800039301961: HISS4024
• 08800039301954: HISS4014
• 08800039317740: HISS6047
• 08800039317733: HISS6037