IMP. EPIKUT PLUS MT16° Ø3,8X13,0MM ILM 3813N

GUDID 07899995274175

IMP. EPIKUT PLUS MT16° Ø3,8X13,0MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995274175
• NIH Device Record Key: 9bf2bc73-7ad7-47b5-b044-0f86c9573b8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMP. EPIKUT PLUS MT16° Ø3,8X13,0MM
• Version Model Number: ILM 3813N
• Catalog Number: ILM 3813N
• 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	07899995274175 [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

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• 07899995239495 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X13MM
• 07899995239501 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X11.5MM
• 07899995239518 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X10MM
• 07899995239525 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X8.5MM
• 07899995239532 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø6.0X13MM
• 07899995239549 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø6.0X11.5MM