IMP. EPIKUT PLUS MT16° Ø5,0X11,5MM ILM 5011N

GUDID 07899995273963

IMP. EPIKUT PLUS MT16° Ø5,0X11,5MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995273963
• NIH Device Record Key: aea5279c-44d3-4f83-8080-9151a7695a74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMP. EPIKUT PLUS MT16° Ø5,0X11,5MM
• Version Model Number: ILM 5011N
• Catalog Number: ILM 5011N
• 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	07899995273963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222231

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: 2023-07-06
• Device Publish Date: 2023-06-28

Devices Manufactured by Sin Sistema de Implante Nacional S/A

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• 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