Anatomic Straight Abutment

GUDID D824S3RC0

Ø3.5mm x L7.5mm, w/ 3mm Shoulder Height, Conical Connection, Regular Platform

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824S3RC0
• NIH Device Record Key: 21e09194-42d8-4b0b-b827-00e50bf5d7f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatomic Straight Abutment
• Version Model Number: S3RC
• Company DUNS: 080321629
• Company Name: SURGIKOR, LLC
• 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: true
• Manufacturing Date: false
• 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
HIBCC	D824S3RC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152555

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

[D824S3RC0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-06

On-Brand Devices [Anatomic Straight Abutment]

• D824S3WC0: Ø4.3mm x L7.5mm, w/ 3mm Shoulder Height, Conical Connection, Wide Platform
• D824S3RH0: Ø3.75mm x L7.5mm, w/ 3mm Shoulder Height, Hex Connection, Regular Platform
• D824S3RC0: Ø3.5mm x L7.5mm, w/ 3mm Shoulder Height, Conical Connection, Regular Platform
• D824S3NC0: Ø3.0mm x L7.5mm, w/ 3mm Shoulder Height, Conical Connection, Narrow Platform
• D824S2WC0: Ø4.3mm x L7.5mm, w/ 2mm Shoulder Height, Conical Connection, Wide Platform
• D824S2RH0: Ø3.75mm x L7.5mm, w/ 2mm Shoulder Height, Hex Connection, Regular Platform
• D824S2RC0: Ø3.5mm x L7.5mm, w/ 2mm Shoulder Height, Conical Connection, Regular Platform
• D824S2NC0: Ø3.0mm x L7.5mm, w/ 2mm Shoulder Height, Conical Connection, Narrow Platform
• D824S1WC0: Ø4.3mm x L7.5mm, w/ 1mm Shoulder Height, Conical Connection, Wide Platform
• D824S1RH0: Ø3.75mm x L7.5mm, w/ 1mm Shoulder Height, Hex Connection, Regular Platform
• D824S1RC0: Ø3. 5mm x L7.5mm, w/ 1mm Shoulder Height, Conical Connection, Regular Platform
• D824S1NC0: Ø3.0mm x L7.5mm, w/ 1mm Shoulder Height, Conical Connection, Narrow Platform