TRINIA 260-614-115

GUDID 00813110020420

TRINIA 40 x 19 x 15mm (I)

BICON, LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00813110020420
• NIH Device Record Key: b385b710-022c-4646-af00-090fa3daa60e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRINIA
• Version Model Number: 260-614-115
• Catalog Number: 260-614-115
• Company DUNS: 945015758
• Company Name: BICON, LLC
• 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: false
• 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

Customer Support Contacts

• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813110020420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133608

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-05

On-Brand Devices [TRINIA]

• 00813110020451: TRINIA 89 x 71 x 15mm (P)
• 00813110020444: TRINIA 89 x 71 x 15mm (I)
• 00813110020420: TRINIA 40 x 19 x 15mm (I)
• 00813110020406: TRINIA 55 x 19 x 15mm (I)
• 00813110020345: TRINIA 98 x 25mm (P)
• 00813110020246: TRINIA 98 x 15mm (P)
• 00813110020147: TRINIA 98 x 25mm (I)
• 00813110020093: TRINIA 98 x 20mm (I)
• 00813110020048: TRINIA 98 x 15mm (I)