RC Screw-retained Abutment

GUDID 06947600303497

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600303497
• NIH Device Record Key: a531fdb0-2d00-4b2c-bb77-78df3b57e922
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RC Screw-retained Abutment
• Version Model Number: 132500
• 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	06947600303497 [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

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

Moist Heat or Steam Sterilization

[06947600303497]

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 [RC Screw-retained Abutment]

• 06947600381365: 132720
• 06947600381358: 132710
• 06947600381341: 132700
• 06947600381334: 132690
• 06947600381327: 132680
• 06947600381310: 132670
• 06947600381303: 132660
• 06947600381297: 132650
• 06947600381280: 132640
• 06947600381273: 132630
• 06947600381266: 132620
• 06947600381259: 132610
• 06947600381242: 132600
• 06947600381235: 132590
• 06947600381228: 132580
• 06947600381211: 132570
• 06947600381204: 132560
• 06947600303541: 132550
• 06947600303534: 132540
• 06947600303527: 132530
• 06947600303510: 132520
• 06947600303503: 132510
• 06947600303497: 132500
• 06947600303480: 132490
• 06947600303473: 132480
• 06947600303466: 132470
• 06947600303459: 132460
• 06947600303442: 132450
• 06947600303435: 132440
• 06947600303305: 132430
• 06947600303299: 132420
• 06947600303282: 132410