NC Screw-retained Abutment

GUDID 06947600381112

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600381112
• NIH Device Record Key: d4a82d7c-e7e9-46c7-a2d5-ac28d3acf1cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC Screw-retained Abutment
• Version Model Number: 131700
• 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	06947600381112 [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

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

Moist Heat or Steam Sterilization

[06947600381112]

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 Screw-retained Abutment]

• 06947600381051: 131640
• 06947600381044: 131630
• 06947600381037: 131620
• 06947600381020: 131610
• 06947600381013: 131600
• 06947600381006: 131590
• 06947600303343: 131500
• 06947600303336: 131490
• 06947600303329: 131480
• 06947600303312: 131470
• 06947600303275: 131460
• 06947600303268: 131450
• 06947600303251: 131440
• 06947600303244: 131430
• 06947600303237: 131420
• 06947600303220: 131410
• 06947600381198: 131780
• 06947600381181: 131770
• 06947600381174: 131760
• 06947600381167: 131750
• 06947600381150: 131740
• 06947600381143: 131730
• 06947600381136: 131720
• 06947600381129: 131710
• 06947600381112: 131700
• 06947600381105: 131690
• 06947600381099: 131680
• 06947600381082: 131670
• 06947600381075: 131660
• 06947600381068: 131650
• 06947600303428: 131580
• 06947600303411: 131570
• 06947600303404: 131560
• 06947600303398: 131550
• 06947600303381: 131540
• 06947600303374: 131530
• 06947600303367: 131520
• 06947600303350: 131510