Address:1540 WEST THORNDALE AVE.,ITASCA,IL,60143,US
Device Description : Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodo Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets.This is a 1.1 gm push syringe of Rely A Bond Paste.
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodo Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets.This is a 1.6g bottle of Rely A Bond primer with fluoride
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : 19 Gauge Tips for use with compatible syringes.
Device Class :
Duns Number: 113170088
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 19 Gauge Tips for use with compatible syringes.
Device Class : 1
Duns Number: 113170088
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Bond Aligner® is intended for use as an orthodontic bonding adhesive for bracket Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces. Can also be used for forming button attachments. Bond Aligner is formulated to work with clear, thermoforming aligner plastics. It is not recommended for use with cloudy (Class C) thermoforming materials.Bond Aligner is a clear, light cure adhesive to adhere metal, ceramic or plastic attachments to a thermoplastic aligner.
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : Blue Gel Etchant is intended for use in etching the tooth surface. Product has Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility blue color. Product contains BAC (Benzalchromium chloride). 5 gm syringe
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : Blue Gel Etchant is intended for use in etching the tooth surface. Product has Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility blue color. Product contains BAC (Benzalchromium chloride). 5 gm syringe.
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : Phase II is intended for use in direct and indirect bonding of orthodontic brack Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. This is Dual Cure.1 X 6g Dual Cure Phase II Adhesive Paste A with Fluoride in screw syringe
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : Excel Fast is intended for use as a bracket adhesive.This is the Fast Set adhesi Excel Fast is intended for use as a bracket adhesive.This is the Fast Set adhesive Part A with Fluoride in a 6gm syringe
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : Excel Fast is intended for use as a bracket adhesive.This is the Fast Set adhesi Excel Fast is intended for use as a bracket adhesive.This is the Fast Set adhesive Part B in a 6gm syringe
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes