IMP. ZYGOMATIC HE Ø4.5XØ3.85X42.5MM IMZ 4142

GUDID 07899995209146

IMP. ZYGOMATIC HE Ø4.5XØ3.85X42.5MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995209146
• NIH Device Record Key: 0ce39789-23f7-46eb-82b4-73d03641cdbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMP. ZYGOMATIC HE Ø4.5XØ3.85X42.5MM
• Version Model Number: IMZ 4142
• Catalog Number: IMZ 4142
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899995209146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203725

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: 2023-12-14
• Device Publish Date: 2023-12-06

Devices Manufactured by Sin Sistema de Implante Nacional S/A

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• 07899995244819 - IMP. ZYGOMATIC MT16° Ø4.0X55MM: 2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X55MM
• 07899995244826 - IMP. ZYGOMATIC MT16° Ø4.0X52.5MM: 2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X52.5MM
• 07899995244833 - IMP. ZYGOMATIC MT16° Ø4.0X50MM: 2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X50MM
• 07899995244840 - IMP. ZYGOMATIC MT16° Ø4.0X47.5MM: 2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X47.5MM
• 07899995244857 - IMP. ZYGOMATIC MT16° Ø4.0X45MM: 2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X45MM
• 07899995244864 - IMP. ZYGOMATIC MT16° Ø4.0X42.5MM: 2024-08-09 IMP. ZYGOMATIC MT16° Ø4.0X42.5MM