BellaTek® Encode®

GUDID 00844868041023

TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 5.7MM (D) X 6.8MM (P) X 5MM (H)

BIOMET 3I, LLC

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00844868041023
• NIH Device Record Key: 4d29db42-a12e-4f0b-baeb-8ff092c67943
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BellaTek® Encode®
• Version Model Number: TEHA5685
• Company DUNS: 186127825
• Company Name: BIOMET 3I, LLC
• Device Count: 1
• DM Exempt: true
• 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
• 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
• 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

• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• 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	00844868041023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173374

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: 3
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-02-27

On-Brand Devices [BellaTek® Encode®]

• 00844868041023: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 5.7MM (D) X 6.8MM (P) X 5MM (H)
• 00844868041016: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 5.7MM (D) X 6.8MM (P) X 3MM (H)
• 00844868041009: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 4.5MM (D) X 6.0MM (P) X 5MM (H)
• 00844868040996: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 4.5MM (D) X 6.0MM (P) X 3MM (H)
• 00844868040989: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 4.5MM (D) X 5.6MM (P) X 7MM (H)
• 00844868040972: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 4.5MM (D) X 5.6MM (P) X 5MM (H)
• 00844868040965: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 4.5MM (D) X 5.6MM (P) X 3MM (H)
• 00844868040958: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 4.5MM (D) X 5.0MM (P) X 5MM (H)
• 00844868040941: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 4.5MM (D) X 5.0MM (P) X 3MM (H)
• 00844868040934: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 5MM (H)
• 00844868040927: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 5.0MM (P) X 3MM (H)
• 00844868040910: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 3.8MM (P) X 7MM (H)
• 00844868040903: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 3.8MM (P) X 5MM (H)
• 00844868040897: TSV™ BELLATEK® ENCODE® HEALING ABUTMENT 3.5MM (D) X 3.8MM (P) X 3MM (H)
• 00844868003267: BELLATEK® ENCODE® HEALING ABUTMENT 6MM(D) X 7.5MM(P) X 8MM(H)
• 00844868003250: BELLATEK® ENCODE® HEALING ABUTMENT 6MM(D) X 7.5MM(P) X 6MM(H)
• 00844868003243: BELLATEK® ENCODE® HEALING ABUTMENT 6MM(D) X 7.5MM(P) X 4MM(H)
• 00844868003236: BELLATEK® ENCODE® HEALING ABUTMENT 6MM(D) X 7.5MM(P) X 3MM(H)
• 00844868003229: BELLATEK® ENCODE® HEALING ABUTMENT 6MM(D) X 6.8MM(P) X 8MM(H)
• 00844868003212: BELLATEK® ENCODE® HEALING ABUTMENT 6MM(D) X 6.8MM(P) X 6MM(H)
• 00844868003205: BELLATEK® ENCODE® HEALING ABUTMENT 6MM(D) X 6.8MM(P) X 4MM(H)
• 00844868003199: BELLATEK® ENCODE® HEALING ABUTMENT 6MM(D) X 6.8MM(P) X 3MM(H)
• 00844868003182: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 8MM(H)
• 00844868003175: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 6MM(H)
• 00844868003168: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H)
• 00844868003151: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 3MM(H)
• 00844868003144: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 6MM(P) X 8MM(H)
• 00844868003137: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H)
• 00844868003120: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)
• 00844868003113: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H)
• 00844868003106: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 8MM(H)
• 00844868003090: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 6MM(H)
• 00844868003083: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H)
• 00844868003076: BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H)
• 00844868003069: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 8MM(H)
• 00844868003052: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 6MM(H)
• 00844868003045: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H)
• 00844868003038: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 3MM(H)
• 00844868003021: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 8MM(H)
• 00844868003014: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H)
• 00844868003007: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H)
• 00844868002994: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H)
• 00844868002987: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 8MM(H)
• 00844868002970: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H)
• 00844868002963: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
• 00844868002956: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)
• 00844868002949: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 8MM(H)
• 00844868002932: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H)
• 00844868002925: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H)
• 00844868002918: BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H)