nt-Preform®

GUDID ENTTN10MI48001

Preform Abutment

NT-Trading GmbH & Co. KG

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: ENTTN10MI48001
• NIH Device Record Key: b2898aea-e24c-4e88-a06e-2e70f15d21cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nt-Preform®
• Version Model Number: N 10.Mi4.800
• Company DUNS: 312800478
• Company Name: NT-Trading GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ENTTN10MI48001 [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

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

[ENTTN10MI48001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-21

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