IMP. EPIKUT MT16° Ø5,0X13,0MM ILM 5013

GUDID 07899995277619

IMP. EPIKUT MT16° Ø5,0X13,0MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995277619
• NIH Device Record Key: eb9d352e-043e-4dbd-93e8-27e6ab47f6f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMP. EPIKUT MT16° Ø5,0X13,0MM
• Version Model Number: ILM 5013
• Catalog Number: ILM 5013
• 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	07899995277619 [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: 2023-06-29
• Device Publish Date: 2023-06-21

Devices Manufactured by Sin Sistema de Implante Nacional S/A

• 07899995241542 - ABUT. INTERFACE MT16° Ø5.5x4.0x6MM IND.: 2025-10-07 ABUT. INTERFACE MT16° Ø5.5x4.0x6MM IND.
• 07899995241559 - ABUT. INTERFACE MT16° Ø5.5x3.0x6MM IND.: 2025-10-07 ABUT. INTERFACE MT16° Ø5.5x3.0x6MM IND.
• 07899995241566 - ABUT. INTERFACE MT16° Ø5.5x2.0x6MM IND.: 2025-10-07 ABUT. INTERFACE MT16° Ø5.5x2.0x6MM IND.
• 07899995241573 - ABUT. INTERFACE MT16° Ø5.5X1.0X6MM IND.: 2025-10-07 ABUT. INTERFACE MT16° Ø5.5X1.0X6MM IND.
• 07899995241597 - ABUT. INTERFACE MT16° Ø5.5x0.5x6MM IND.: 2025-10-07 ABUT. INTERFACE MT16° Ø5.5x0.5x6MM IND.
• 07899995241610 - ABUT. INTERFACE MT16° Ø5.5x4.0x4MM IND.: 2025-10-07 ABUT. INTERFACE MT16° Ø5.5x4.0x4MM IND.
• 07899995241627 - ABUT. INTERFACE MT16° Ø5.5x3.0x4MM IND.: 2025-10-07 ABUT. INTERFACE MT16° Ø5.5x3.0x4MM IND.
• 07899995241634 - ABUT. INTERFACE MT16° Ø5.5x2.0x4MM IND.: 2025-10-07 ABUT. INTERFACE MT16° Ø5.5x2.0x4MM IND.