NC/RC Coping for screw-retained abutment

GUDID 06947600381389

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600381389
• NIH Device Record Key: 6fb957e6-b3e1-4fcb-99d9-df258fcdcbbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC/RC Coping for screw-retained abutment
• Version Model Number: 171480
• Company DUNS: 527603266
• Company Name: BIO CONCEPT CO.,LTD
• 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: 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	06947600381389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212364

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

[06947600381389]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-12
• Device Publish Date: 2022-09-02

On-Brand Devices [NC/RC Coping for screw-retained abutment]

• 06947600381402: 171480N
• 06947600381389: 171480
• 06947600303589: 171420N
• 06947600303572: 171420