UOTR-45551

GUDID 07290112853578

Straight abutment D4.5 H5.5 GH1 Conical 11deg RP

UNIQA DENTAL LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07290112853578
• NIH Device Record Key: 138c0f8a-6879-40bd-b5ff-5b2e3d8a7826
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: UOTR-45551
• Catalog Number: UOTR-45551
• Company DUNS: 532098872
• Company Name: UNIQA DENTAL LTD
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• 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	07290112853578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180598

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

[07290112853578]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-12
• Device Publish Date: 2024-09-04

Devices Manufactured by UNIQA DENTAL LTD

• 07290112853110 - NA: 2024-11-14 Castable sleeve for MUA D-type
• 07290112852236 - NA: 2024-09-27 Analog MUA D-type
• 07290112852410 - NA: 2024-09-18 Manual screw driver for abutments H8 Hex1.25
• 07290112852380 - NA: 2024-09-17 Manual screw driver for abutments H15 Hex1.25
• 07290112852717 - NA: 2024-09-17 Ratchet screw driver for abutments H10 Hex1.25
• 07290112852724 - NA: 2024-09-17 Ratchet screw driver for abutments H15 Hex1.25
• 07290112852731 - NA: 2024-09-17 Ratchet screw driver for abutments H7 Hex1.25
• 07290112852748 - NA: 2024-09-17 Ratchet screw driver for implants 2.4mm H10