EZTETIC® BELLATEK® ENCODE®

GUDID 00844868045373

EZTETIC® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 2.9MM(D) 4.5MM(P) 5MM(H)

BIOMET 3I, LLC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00844868045373
• NIH Device Record Key: fcdacaad-129a-4b69-b3f6-b930f8c0b578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZTETIC® BELLATEK® ENCODE®
• Version Model Number: CEEHA345
• Company DUNS: 186127825
• Company Name: BIOMET 3I, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844868045373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212730

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2022-06-15
• Device Publish Date: 2022-06-07

On-Brand Devices [EZTETIC® BELLATEK® ENCODE®]

• 00844868045380: EZTETIC® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 2.9MM(D) 4.5MM(P) 7MM(H)
• 00844868045373: EZTETIC® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 2.9MM(D) 4.5MM(P) 5MM(H)
• 00844868045366: EZTETIC® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 2.9MM(D) 4.5MM(P) 3MM(H)
• 00844868045359: EZTETIC® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 2.9MM(D) 3.7MM(P) 7MM(H)
• 00844868045342: EZTETIC® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 2.9MM(D) 3.7MM(P) 5MM(H)
• 00844868045335: EZTETIC® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 2.9MM(D) 3.7MM(P) 3MM(H)