Unitite UCM 5085N

GUDID 07899995215802

IMPLANT UNITITE MORSE Ø 5.0 X 8.5MM

Sin Sistema de Implante Nacional S/A

Screw endosteal dental implant, one-piece

• Primary Device ID: 07899995215802
• NIH Device Record Key: 15104712-97c7-46f0-9612-9066c548808a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unitite
• Version Model Number: UCM 5085N
• Catalog Number: UCM 5085N
• 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: 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	07899995215802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170392

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: 2022-07-08
• Device Publish Date: 2022-06-30

On-Brand Devices [Unitite ]

• 07899995215925: IMPLANT UNITITE MORSE SLIM Ø 2.9X13MM
• 07899995215918: IMPLANT UNITITE MORSE SLIM Ø 2.9X11.5MM
• 07899995215901: IMPLANT UNITITE MORSE SLIM Ø 2.9X10MM
• 07899995215895: IMPLANT UNITITE MORSE COMPACT Ø 6.0X7MM
• 07899995215888: IMPLANT UNITITE MORSE COMPACT Ø 6.0X6MM
• 07899995215871: IMPLANT UNITITE MORSE COMPACT Ø 6.0X5MM
• 07899995215864: IMPLANT UNITITE MORSE COMPACT Ø 5.0X7MM
• 07899995215857: IMPLANT UNITITE MORSE COMPACT Ø 5.0X6MM
• 07899995215840: IMPLANT UNITITE MORSE COMPACT Ø 5.0X5MM
• 07899995215833: IMPLANT UNITITE MORSE COMPACT Ø 4.0X7MM
• 07899995215826: IMPLANT UNITITE MORSE COMPACT Ø 4.0X6MM
• 07899995215819: IMPLANT UNITITE MORSE COMPACT Ø 4.0X5MM
• 07899995215802: IMPLANT UNITITE MORSE Ø 5.0 X 8.5MM
• 07899995215796: IMPLANT UNITITE MORSE Ø 5.0 X 15MM
• 07899995215789: IMPLANT UNITITE MORSE Ø 5.0 X 13MM
• 07899995215772: IMPLANT UNITITE MORSE Ø 5.0 X 11.5MM
• 07899995215765: IMPLANT UNITITE MORSE Ø 5.0 X 10MM
• 07899995215758: IMPLANT UNITITE MORSE Ø 4.3 X 8.5MM
• 07899995215741: IMPLANT UNITITE MORSE Ø 4.3 X 15MM
• 07899995215734: IMPLANT UNITITE MORSE Ø 4.3 X 13MM
• 07899995215727: IMPLANT UNITITE MORSE Ø 4.3 X 11.5MM
• 07899995215710: IMPLANT UNITITE MORSE Ø 4.3 X 10MM
• 07899995215703: IMPLANT UNITITE MORSE Ø 3.5 X 8.5MM
• 07899995215697: IMPLANT UNITITE MORSE Ø 3.5 X 15MM
• 07899995215680: IMPLANT UNITITE MORSE Ø 3.5 X 13MM
• 07899995215673: IMPLANT UNITITE MORSE Ø 3.5 X 11.5MM
• 07899995215666: IMPLANT UNITITE MORSE Ø 3.5 X 10MM