Bollard Skeletal Anchor

GUDID 05430000515085

Tita-Link BVBA

Subperiosteal dental implant material

• Primary Device ID: 05430000515085
• NIH Device Record Key: f8a8f5d9-63c4-40ff-b7d5-221ac9cf722d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bollard Skeletal Anchor
• Version Model Number: BH-LR-16
• Company DUNS: 371014109
• Company Name: Tita-Link BVBA
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430000515085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091051

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[05430000515085]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-01

On-Brand Devices [Bollard Skeletal Anchor]

• 05430000515122: BH-UR-19-Y
• 05430000515115: BH-UL-19-Y
• 05430000515108: BH-UR-18-PED
• 05430000515092: BH-UL-18-PED
• 05430000515085: BH-LR-16
• 05430000515078: BH-LL-16
• 05430000515061: BH-UR-21
• 05430000515054: BH-UL-21
• 05430000515047: B-LR-16
• 05430000515030: B-LL-16
• 05430000515023: B-UR-21
• 05430000515016: B-UL-21