Solid Abutment Cap

GUDID 08800039317993

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

Dental implant system

• Primary Device ID: 08800039317993
• NIH Device Record Key: e8552b5e-03d8-4094-9eff-71ffd3bb93f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solid Abutment Cap
• Version Model Number: OISS655C
• 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: true
• 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	08800039317993 [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

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

[08800039317993]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-23
• Device Publish Date: 2024-10-15

On-Brand Devices [Solid Abutment Cap]

• 08800039318037: OISS607C
• 08800039318020: OISS605C
• 08800039318013: OISS604C
• 08800039318006: OISS657C
• 08800039317993: OISS655C
• 08800039317986: OISS654C
• 08800039317979: OISS557C
• 08800039317962: OISS555C
• 08800039317955: OISS554C
• 08800039317948: OISS507C
• 08800039317931: OISS505C
• 08800039317924: OISS504C
• 08800039317917: OISS457C
• 08800039317900: OISS455C
• 08800039317894: OISS454C
• 08800039317887: OISS407C
• 08800039317870: OISS405C
• 08800039317863: OISS404C