Equator Abutment

GUDID 06947600313533

BIO CONCEPT CO.,LTD

Dental implant system

• Primary Device ID: 06947600313533
• NIH Device Record Key: 54f3c9db-ba0f-4244-adac-996d1f218f58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equator Abutment
• Version Model Number: 338060-1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947600313533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192274

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

[06947600313533]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-24
• Device Publish Date: 2020-07-16

On-Brand Devices [Equator Abutment]

• 06947600313595: 338260-1
• 06947600313588: 338250-1
• 06947600313571: 338240-1
• 06947600313564: 338230-1
• 06947600313557: 338220-1
• 06947600313540: 338210-1
• 06947600313533: 338060-1
• 06947600313526: 338050-1
• 06947600313519: 338040-1
• 06947600313502: 338030-1
• 06947600313496: 338020-1
• 06947600313489: 338010-1
• 06947600313472: 338260
• 06947600313434: 338250
• 06947600313427: 338240
• 06947600313410: 338230
• 06947600313403: 338220
• 06947600313397: 338210
• 06947600313380: 338060
• 06947600313373: 338050
• 06947600313366: 338040
• 06947600313359: 338030
• 06947600313342: 338020
• 06947600313335: 338010
• 06947600306931: 134260-1
• 06947600306924: 134250-1
• 06947600306917: 134240-1
• 06947600306900: 134230-1
• 06947600306894: 134220-1
• 06947600306887: 134210-1
• 06947600306870: 134060-1
• 06947600306863: 134050-1
• 06947600306856: 134040-1
• 06947600306849: 134030-1
• 06947600306832: 134020-1
• 06947600306306: 134260
• 06947600306290: 134250
• 06947600306283: 134240
• 06947600306276: 134230
• 06947600306269: 134220
• 06947600306252: 134210
• 06947600305958: 134060
• 06947600305941: 134050
• 06947600305934: 134040
• 06947600305927: 134030
• 06947600305910: 134020