IMP. ZYGOMATIC MT16° Ø4.0X57.5MM ILMZ 4057E

GUDID 07899995244802

IMP. ZYGOMATIC MT16° Ø4.0X57.5MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995244802
• NIH Device Record Key: e9b9999b-46d3-4dcf-9cc1-057a56d0eae3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMP. ZYGOMATIC MT16° Ø4.0X57.5MM
• Version Model Number: ILMZ 4057E
• Catalog Number: ILMZ 4057E
• Company DUNS: 904569092
• Company Name: Sin Sistema de Implante Nacional S/A
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899995244802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231127

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-09
• Device Publish Date: 2024-08-01

Devices Manufactured by Sin Sistema de Implante Nacional S/A

• 07899995262462 - ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X2.5X 45° INDEX: 2024-12-23 ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X2.5X 45° INDEX
• 07899995262479 - ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X1.5X 45° INDEX: 2024-12-23 ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X1.5X 45° INDEX
• 07899995263483 - ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X2X 45° INDEX: 2024-12-23 ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X2X 45° INDEX
• 07899995263537 - DRILL DIAMOND Ø4.0X40MM THICK: 2024-12-23 DRILL DIAMOND Ø4.0X40MM THICK
• 07899995264206 - DRILL DIAMOND ROUND Ø4.0MM: 2024-12-23 DRILL DIAMOND ROUND Ø4.0MM
• 07899995244796 - IMP. ZYGOMATIC MT16° Ø4.0X60MM: 2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X60MM
• 07899995244802 - IMP. ZYGOMATIC MT16° Ø4.0X57.5MM: 2024-08-09IMP. ZYGOMATIC MT16° Ø4.0X57.5MM
• 07899995244802 - IMP. ZYGOMATIC MT16° Ø4.0X57.5MM: 2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X57.5MM
• 07899995244819 - IMP. ZYGOMATIC MT16° Ø4.0X55MM: 2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X55MM