UT Fixture

GUDID 08800026101222

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026101222
• NIH Device Record Key: 9fc6332b-c9d7-43a5-87c7-52f2d46a418e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UT Fixture
• Version Model Number: FUT53115
• Company DUNS: 688857820
• Company Name: WARANTEC.Co.,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: 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	08800026101222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172345

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: 2023-04-20
• Device Publish Date: 2023-04-12

On-Brand Devices [UT Fixture]

• 08800026101277: FUT63115
• 08800026101260: FUT63100
• 08800026101253: FUT63085
• 08800026101246: FUT63070
• 08800026101239: FUT53130
• 08800026101222: FUT53115
• 08800026101215: FUT53100
• 08800026101208: FUT53085
• 08800026101192: FUT53070
• 08800026101185: FUT48130
• 08800026101178: FUT48115
• 08800026101161: FUT48100
• 08800026101154: FUT48085
• 08800026101147: FUT48070
• 08800026101130: FUT43130
• 08800026101123: FUT43115
• 08800026101116: FUT43100
• 08800026101109: FUT43085
• 08800026101093: FUT43070