IMP. EPIKUT MT16° Ø3,8X11,5MM ILM 3811

GUDID 07899995280534

IMP. EPIKUT MT16° Ø3,8X11,5MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995280534
• NIH Device Record Key: 3f4a4fb1-6e47-4d7b-b572-d6bf576762be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMP. EPIKUT MT16° Ø3,8X11,5MM
• Version Model Number: ILM 3811
• Catalog Number: ILM 3811
• 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	07899995280534 [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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by Sin Sistema de Implante Nacional S/A

• 07899995243805 - DRIVER RATCHET HEX1.4 EXT. LONG ANG.: 2025-12-31 DRIVER RATCHET HEX1.4 EXT. LONG ANG.
• 07899995243812 - DRIVER RATCHET HEX1.4 LONG ANG.: 2025-12-31 DRIVER RATCHET HEX1.4 LONG ANG.
• 07899995243829 - DRIVER RATCHET HEX1.4 MEDIUM ANG.: 2025-12-31 DRIVER RATCHET HEX1.4 MEDIUM ANG.
• 07899995243836 - DRIVER RATCHET HEX1.4 SHORT ANG.: 2025-12-31 DRIVER RATCHET HEX1.4 SHORT ANG.
• 07899995243843 - DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.: 2025-12-31 DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.
• 07899995243850 - DRIVER HANDPIECE HEX.1.4MM LONG ANG.: 2025-12-31 DRIVER HANDPIECE HEX.1.4MM LONG ANG.
• 07899995243874 - DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.: 2025-12-31 DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.
• 07899995243881 - DRIVER HANDPIECE HEX.1.4MM SHORT ANG.: 2025-12-31 DRIVER HANDPIECE HEX.1.4MM SHORT ANG.