Comp Plus "T"™ LR 2nd Bicuspid Roth .022 710-928T

GUDID 00842452100293

Lower Right 2nd Bicuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

ORTHO SPECIALTIES

Orthodontic bracket, plastic, single-use
Primary Device ID00842452100293
NIH Device Record Key88d49018-b5ff-4db2-ad87-c479727f2e45
Commercial Distribution StatusIn Commercial Distribution
Brand NameComp Plus "T"™ LR 2nd Bicuspid Roth .022
Version Model Number710-928T
Catalog Number710-928T
Company DUNS011050583
Company NameORTHO SPECIALTIES
Device Count1
DM Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-637-1237
Emailcontactus@orthospecialties.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842452100293 [Primary]

FDA Product Code

DYWBracket, Plastic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by ORTHO SPECIALTIES

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00842452100507 - Adhere™ Light Cure Adhesive Kit2018-07-06 Light Cure Adhesive Kit For Direct Bonding Orthodontic Brackets
00842452100514 - Adhere™ Light Cure Adhesive Tips2018-07-06 Light Cure Adhesive Preloaded Tips For Direct Bonding Orthodontic Brackets
00842452100521 - Adhere™ Light Cure Adhesive Primer2018-07-06 Light Cure Adhesive Primer For Direct Bonding Orthodontic Brackets
00842452100538 - Adhere™ Enamel Etch Conditioner2018-07-06 Phosphoric Acid Etch For Direct Bonding Orthodontic Brackets
00842452100545 - Adhere™ Self Cure Adhesive Kit2018-07-06 Self Curing Adhesive Kit For Direct Bonding Orthodontic Brackets
00842452100552 - Adhere™ Self Cure Adhesive Tips2018-07-06 Self Curing Adhesive Preloaded Tips For Direct Bonding Orthodontic Brackets
00842452100569 - Adhere™ Self Cure Activator2018-07-06 Self Curing Adhesive Primer For Direct Bonding Orthodontic Brackets

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