Equator Abutment,Φ 4.8mm,GH 6mm

GUDID 06947600302865

BIO CONCEPT Co., Ltd.

Dental implant system

• Primary Device ID: 06947600302865
• NIH Device Record Key: b8f07da5-7f84-4e5a-989a-c78ac2e19403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equator Abutment,Φ 4.8mm,GH 6mm
• Version Model Number: 034060-1
• 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	06947600302865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150388

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

[06947600302865]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [Equator Abutment,Φ 4.8mm,GH 6mm]

• 06947600302865: 034060-1
• 06947600302742: 034060