Bonding Buttons 82604

GUDID D746826041

Bonding Buttons - Pack of 10

RAINTREE ESSIX INC.

Orthodontic pliers
Primary Device IDD746826041
NIH Device Record Key8d55a1c6-b0d9-4968-81ed-4f1e3b2866af
Commercial Distribution Discontinuation2021-02-18
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBonding Buttons
Version Model Number82604
Catalog Number82604
Company DUNS801157132
Company NameRAINTREE ESSIX INC.
Device Count10
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD746826040 [Unit of Use]
HIBCCD746826041 [Primary]

FDA Product Code

NXCAligner, sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-09-23
Device Publish Date2016-09-24

Devices Manufactured by RAINTREE ESSIX INC.

D74627310701 - VISTADENT® OC2021-12-17 VISTADENT® OC CONSULTANT
D7462731070U1 - VISTADENT® OC2021-12-17 VISTADENT® OC CONSULTANT UPDATE
D74627310991 - VISTADENT® OC2021-12-17 VISTADENT® OC COMPLETE
D7462731099U1 - VISTADENT® OC2021-12-17 VISTADENT® OC COMPLETE UPDATE
D7462731170L1 - VISTADENT® OC2021-12-17 VISTADENT® OC CONSULTANT (LATIN AM)
D7462731199L1 - VISTADENT® OC2021-12-17 VISTADENT® OC COMPLETE LATIN AMERICA
D74627313991 - VISTADENT® OC2021-12-17 VISTADENT® OC SUBSCRIPTION EAST
D74627314991 - VISTADENT® OC2021-12-17 VISTADENT® OC SUBSCRIPTION LAT AMERICA

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.