TSV® BELLATEK® ENCODE®

GUDID 00844868045915

TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 7.5MM(P) 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
Primary Device ID00844868045915
NIH Device Record Keyacb4b961-e5c6-44f5-8124-4c00ae991f45
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSV® BELLATEK® ENCODE®
Version Model NumberTEEHA475
Company DUNS186127825
Company NameBIOMET 3I, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)342-5454
Email3iPBG-CS@biomet.com
Phone+1(800)342-5454
Email3iPBG-CS@biomet.com
Phone+1(800)342-5454
Email3iPBG-CS@biomet.com
Phone+1(800)342-5454
Email3iPBG-CS@biomet.com
Phone+1(800)342-5454
Email3iPBG-CS@biomet.com
Phone+1(800)342-5454
Email3iPBG-CS@biomet.com
Phone+1(800)342-5454
Email3iPBG-CS@biomet.com
Phone+1(800)342-5454
Email3iPBG-CS@biomet.com
Phone+1(800)342-5454
Email3iPBG-CS@biomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Height5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100844868045915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-15
Device Publish Date2022-06-07

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

00844868045984TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 5.7MM(D) 7.5MM(P) 5MM(H)
00844868045977TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 5.7MM(D) 7.5MM(P) 3MM(H)
00844868045960TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 5.7MM(D) 6.8MM(P) 5MM(H)
00844868045953TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 5.7MM(D) 6.8MM(P) 3MM(H)
00844868045946TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 5.7MM(D) 5.7MM(P) 5MM(H)
00844868045939TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 5.7MM(D) 5.7MM(P) 3MM(H)
00844868045922TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 7.5MM(P) 7MM(H)
00844868045915TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 7.5MM(P) 5MM(H)
00844868045908TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 7.5MM(P) 3MM(H)
00844868045892TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 6.5MM(P) 7MM(H)
00844868045885TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 6.5MM(P) 5MM(H)
00844868045878TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 6.5MM(P) 3MM(H)
00844868045861TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 5.5MM(P) 7MM(H)
00844868045854TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 5.5MM(P) 5MM(H)
00844868045847TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 5.5MM(P) 3MM(H)
00844868045830TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 4.5MM(P) 7MM(H)
00844868045823TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 4.5MM(P) 5MM(H)
00844868045816TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 4.5MM(P) 3MM(H)
00844868045809TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 6.5MM(P) 7MM(H)
00844868045793TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 6.5MM(P) 5MM(H)
00844868045786TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 6.5MM(P) 3MM(H)
00844868045779TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 7MM(H)
00844868045762TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 5MM(H)
00844868045755TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 3MM(H)
00844868045748TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 3.8MM(P) 7MM(H)
00844868045731TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 3.8MM(P) 5MM(H)
00844868045724TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 3.8MM(P) 3MM(H)

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