Stealth Abutment 260-250-400

GUDID 00813110021847

4.0 x 3.5mm 0° Stealth Abutment - 2.5mm Post

BICON, LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00813110021847
• NIH Device Record Key: 15b9657e-6cd5-46e6-a652-2e2167b746ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stealth Abutment
• Version Model Number: 260-250-400
• Catalog Number: 260-250-400
• 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: 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: 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	00813110021847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092035

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-03-08

On-Brand Devices [Stealth Abutment]

• 00813110022462: 6.5 x 4.0mm 10° Stealth Abutment - 3.0mm Post
• 00813110022455: 6.5 x 4.0mm 0° Stealth Abutment - 3.0mm Post
• 00813110022448: 6.5 x 2.0mm 10° Stealth Abutment - 3.0mm Post
• 00813110022431: 6.5 x 2.0mm 0° Stealth Abutment - 3.0mm Post
• 00813110022318: 4.0 x 3.5mm 0° Stealth Abutment - 3.0mm Post
• 00813110022301: 5.0 x 8.0mm 0° Stealth Abutment - 3.0mm Post
• 00813110022295: 5.0 x 6.0mm 10° Stealth Abutment - 3.0mm Post
• 00813110022288: 5.0 x 6.0mm 0° Stealth Abutment - 3.0mm Post
• 00813110022271: 5.0 x 4.0mm 10° Stealth Abutment - 3.0mm Post
• 00813110022264: 5.0 x 4.0mm 0° Stealth Abutment - 3.0mm Post
• 00813110022257: 5.0 x 3.0mm 10° Stealth Abutment - 3.0mm Post
• 00813110022240: 5.0 x 3.0mm 0° Stealth Abutment - 3.0mm Post
• 00813110022233: 5.0 x 2.0mm 10° Stealth Abutment - 3.0mm Post
• 00813110022226: 5.0 x 2.0mm 0° Stealth Abutment - 3.0mm Post
• 00813110022219: 4.0 x 1.5mm 0° Stealth Abutment - 3.0mm Post
• 00813110021847: 4.0 x 3.5mm 0° Stealth Abutment - 2.5mm Post
• 00813110021830: 5.0 x 6.0mm 10° Stealth Abutment - 2.5mm Post
• 00813110021823: 5.0 x 6.0mm 0° Stealth Abutment - 2.5mm Post
• 00813110021816: 5.0 x 4.0mm 10° Stealth Abutment - 2.5mm Post
• 00813110021809: 5.0 x 4.0mm 0° Stealth Abutment - 2.5mm Post
• 00813110021793: 5.0 x 3.0mm 10° Stealth Abutment - 2.5mm Post
• 00813110021786: 5.0 x 3.0mm 0° Stealth Abutment - 2.5mm Post
• 00813110021779: 5.0 x 2.0mm 10° Stealth Abutment - 2.5mm Post
• 00813110021762: 5.0 x 2.0mm 0° Stealth Abutment - 2.5mm Post
• 00813110021755: 4.0 x 1.5mm 0° Stealth Abutment - 2.5mm Post
• 00813110021335: 4.0 x 3.5mm 0° Stealth Abutment - 2.0mm Post
• 00813110021328: 5.0 x 6.0mm 10° Stealth Abutment - 2.0mm Post
• 00813110021311: 5.0 x 6.0mm 0° Stealth Abutment - 2.0mm Post
• 00813110021304: 5.0 x 4.0mm 10° Stealth Abutment - 2.0mm Post
• 00813110021298: 5.0 x 4.0mm 0° Stealth Abutment - 2.0mm Post
• 00813110021281: 5.0 x 2.0mm 10° Stealth Abutment - 2.0mm Post
• 00813110021274: 5.0 x 2.0mm 0° Stealth Abutment - 2.0mm Post
• 00813110021267: 4.0 x 1.5mm 0° Stealth Abutment - 2.0mm Post
• 00813110021250: 3.5 x 3.0mm 0° Stealth Abutment - 2.0mm Post
• 00813110021243: 3.5 x 1.5mm 0° Stealth Abutment - 2.0mm Post