Standard Plus Implant

GUDID 06947600300007

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600300007
• NIH Device Record Key: 18e0e270-dc3e-4991-9196-bf97e847f794
• Commercial Distribution Discontinuation: 2018-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Standard Plus Implant
• Version Model Number: 011010
• Company DUNS: 527603266
• Company Name: BIO CONCEPT CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947600300007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150388

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-05
• Device Publish Date: 2016-06-07

On-Brand Devices [Standard Plus Implant]

• 06947600300229: 012180
• 06947600300212: 012170
• 06947600300205: 012160
• 06947600300182: 012140
• 06947600300175: 012130
• 06947600300168: 012120
• 06947600300151: 012110
• 06947600300137: 012090
• 06947600300120: 012080
• 06947600300113: 012070
• 06947600300106: 012060
• 06947600300083: 012040
• 06947600300076: 012030
• 06947600300069: 012020
• 06947600300052: 012010
• 06947600300045: 011040
• 06947600300038: 011030
• 06947600300021: 011020
• 06947600300014: 011010
• 06947600300007: 011010