ORTHODONTIC KIT KOR

GUDID 07899995216175

ORTHODONTIC KIT

Sin Sistema de Implante Nacional S/A

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 07899995216175
• NIH Device Record Key: cdce4c36-67b9-48e8-b31a-93920d8672b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHODONTIC KIT
• Version Model Number: KOR
• Catalog Number: KOR
• 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: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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	07899995216175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222005

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

[07899995216175]

Moist Heat or Steam Sterilization

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

• 07899995254634 - CAD-CAM ABUTMENT: 2025-08-12 ABUT. INTERFACE MT16° 4MM
• 07899995256447 - CAD-CAM ABUTMENT: 2025-08-12 ABUT. INTERFACE MT16° 5MM
• 07899995256577 - CAD-CAM ABUTMENT: 2025-08-12 ABUT. INTERFACE MT16° 3MM
• 07899995256676 - CAD-CAM ABUTMENT: 2025-08-12 ABUT. INTERFACE MT16° 1.5MM
• 07899995256768 - CAD-CAM ABUTMENT: 2025-08-12 ABUT. INTERFACE MT16° 0.5MM
• 07899995243744 - Epikut surgical kit: 2025-03-03 Epikut surgical kit
• 07899995243775 - Epikut surgical kit: 2025-03-03 Epikut surgical kit
• 07899995262462 - ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X2.5X 45° INDEX: 2024-12-23 ABUTMENT MINI ANGLED MORSE TAPER Ø4,8X2.5X 45° INDEX