BRE 80350000

GUDID ENTTBRE803500001

NT-Trading GmbH & Co. KG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: ENTTBRE803500001
• NIH Device Record Key: 94f5142a-8ccd-4c19-9f29-54ae3f74f571
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BRE 80350000
• Catalog Number: BRE 80350000
• Company DUNS: 312800478
• Company Name: NT-Trading GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ENTTBRE803500001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111935

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

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[ENTTBRE803500001]

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[ENTTBRE803500001]

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[ENTTBRE803500001]

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[ENTTBRE803500001]

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[ENTTBRE803500001]

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[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

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[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

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[ENTTBRE803500001]

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[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

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[ENTTBRE803500001]

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[ENTTBRE803500001]

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[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

[ENTTBRE803500001]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-08-23

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• ENTTBEG5LA41001 - -: 2023-07-31 Mill Lab Analog
• ENTTBEG5LA45001 - -: 2023-07-31 Mill Lab Analog
• ENTTBEG5LA55001 - -: 2023-07-31 Mill Lab Analog
• ENTTBEG9S3D32371 - -: 2023-07-31 Scanbody 3D-Guide®
• ENTTBEG9S3D41001 - -: 2023-07-31 Scanbody 3D-Guide®
• ENTTBEG9S3D45001 - -: 2023-07-31 Scanbody 3D-Guide®