Equator Block-out Spacers

GUDID 06947600313670

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600313670
• NIH Device Record Key: 0b06d39d-93c4-444d-84a9-9b7f2799aba2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equator Block-out Spacers
• Version Model Number: 378070 V20
• 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	06947600313670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192274

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-20
• Device Publish Date: 2020-07-10

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