RN Positioning Cylinder for Solid Abutment 032010

GUDID 06947600302667

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600302667
• NIH Device Record Key: 5d9851af-1029-418e-b09d-ae4fd3f685bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RN Positioning Cylinder for Solid Abutment 032010
• Version Model Number: 062060
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947600302186 [Primary]
GS1	06947600302667 [Package]; Contains: 06947600302186; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150388

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

[06947600302667]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-19
• Device Publish Date: 2016-09-01

Devices Manufactured by BIO CONCEPT CO.,LTD

• 06947600316596 - BV Guided Kit,BV: 2024-09-26
• 06947600319016 - Anchor Drill,Φ1.3mm,L33mm: 2024-09-26
• 06947600319030 - Initial Drill,Φ3.5mm/Φ5.7mm,L5mm: 2024-09-26
• 06947600319047 - Initial Drill,Φ2.7mm/Φ5mm,L5mm: 2024-09-26
• 06947600319054 - Initial Drill,Φ3.5mm/Φ5mm,L5mm: 2024-09-26
• 06947600319061 - Initial Drill,Φ2.7mm/Φ5mm,L7mm: 2024-09-26
• 06947600319078 - Initial Drill,Φ2.7mm/Φ5mm,L8.5mm: 2024-09-26
• 06947600319085 - Initial Drill,Φ2.7mm/Φ5mm,L10mm: 2024-09-26