IMP. ZYGOMATIC HE Ø4.5XØ3.85X52.5MM IMZ 4152

GUDID 07899995209184

IMP. ZYGOMATIC HE Ø4.5XØ3.85X52.5MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995209184
• NIH Device Record Key: f16844d4-cc94-45ce-96d3-de740ae8b483
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMP. ZYGOMATIC HE Ø4.5XØ3.85X52.5MM
• Version Model Number: IMZ 4152
• Catalog Number: IMZ 4152
• 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	07899995209184 [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

• 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.