NC/RC Screw, for screw-retained abutment,straight 0°, GH1mm

GUDID 06947600381433

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600381433
• NIH Device Record Key: 1c8b23a8-52cb-4020-be1d-1f9a0948f698
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC/RC Screw, for screw-retained abutment,straight 0°, GH1mm
• Version Model Number: 141020
• 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	06947600381433 [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

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

[06947600381433]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-13
• Device Publish Date: 2022-09-05

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