nt-Preform® BIO 10.MI3.000.05

GUDID ENTTBIO10MI3000051

NT-Trading GmbH & Co. KG

Dental prosthesis/implant abutment screw

• Primary Device ID: ENTTBIO10MI3000051
• NIH Device Record Key: 5c744ac0-7e24-4f5a-9fbe-da32ec4cfcfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nt-Preform®
• Version Model Number: BIO 10.MI3.000.05
• Catalog Number: BIO 10.MI3.000.05
• 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

• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ENTTBIO10MI3000051 [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

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

Dry Heat Sterilization

[ENTTBIO10MI3000051]

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

On-Brand Devices [nt-Preform®]

• ENTTBEG10MI3237051: BEG 10.MI3.237.05
• ENTTUPR10MI5000051: UPR 10.MI5.000.05
• ENTTUTG10MI5000051: UTG 10.MI5.000.05
• ENTTUTG10MI3342051: UTG 10.MI3.342.05
• ENTTUPR10MI4200051: UPR 10.MI4.200.05
• ENTTUPR10MI3800051: UPR 10.MI3.800.05
• ENTTUPR10MI3300051: UPR 10.MI3.300.05
• ENTTTHO10MI6000051: THO 10.MI6.000.05
• ENTTTHO10MI5000051: THO 10.MI5.000.05
• ENTTTHO10MI4500051: THO 10.MI4.500.05
• ENTTTHO10MI4000051: THO 10.MI4.000.05
• ENTTTHO10MI3500051: THO 10.MI3.500.05
• ENTTT10MI55001: Preform Abutment
• ENTTT10MI550005AG1: Preform Abutment
• ENTTT10MI5500051: Preform Abutment
• ENTTT10MI45001: Preform Abutment
• ENTTT10MI450005AG1: Preform Abutment
• ENTTT10MI4500051: Preform Abutment
• ENTTT10MI38001: Preform Abutment
• ENTTT10MI380005AG1: Preform Abutment
• ENTTT10MI3800051: Preform Abutment
• ENTTT10MI34001: Preform Abutment
• ENTTT10MI340005AG1: Preform Abutment
• ENTTT10MI3400051: Preform Abutment
• ENTTSEV10MI5400051: SEV 10.MI5.400.05
• ENTTSEV10MI4800051: SEV 10.MI4.800.05
• ENTTSEV10MI4200051: SEV 10.MI4.200.05
• ENTTSEV10MI3600051: SEV 10.MI3.600.05
• ENTTSEV10MI3000051: SEV 10.MI3.000.05
• ENTTS10MI45501: Preform Abutment
• ENTTS10MI455005AG1: Preform Abutment
• ENTTS10MI4550051: Preform Abutment
• ENTTS10MI35401: Preform Abutment
• ENTTS10MI354005AG1: Preform Abutment
• ENTTS10MI3540051: Preform Abutment
• ENTTR10MI57001: Preform Abutment
• ENTTR10MI570005AG1: Preform Abutment
• ENTTR10MI5700051: Preform Abutment
• ENTTR10MI45001: Preform Abutment
• ENTTR10MI450005AG1: Preform Abutment
• ENTTR10MI4500051: Preform Abutment
• ENTTR10MI35001: Preform Abutment
• ENTTR10MI350005AG1: Preform Abutment
• ENTTR10MI3500051: Preform Abutment
• ENTTNEO10MI3555051: NEO 10.MI3.555.05
• ENTTN10MI65051: Preform Abutment
• ENTTN10MI650505AG1: Preform Abutment
• ENTTN10MI6505051: Preform Abutment
• ENTTN10MI65001: Preform Abutment
• ENTTN10MI480505AG1: Preform Abutment