RELIANCE ORTHODONTIC PRODUCTS INC

Address:1540 WEST THORNDALE AVE.,ITASCA,IL,60143,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Wire, Orthodontic (DZC) (4) Applicator, Resin (KXR) (2) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (1) Agent, Tooth Bonding, Resin (KLE) (1) Instrument, Ligature Tucking, Orthodontic (ECP) (1) Material, Tooth Shade, Resin (EBF) (1)

Premarket Exempt

No Yes

Clear

Stick and Place - D798SNP161 Catalog Number : SNP16

Device Description : Stick and Place veneer placing instruments

Device Class :

Duns Number: 113170088

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : Yes

Device Count : 16

sponge pellets - D798SP1 Catalog Number : SP

Device Description : Sponge applicators for sealants and resins.

Device Class :

Duns Number: 113170088

Premarket Exempt : Yes

Product Code : ECP

Prescription Use : No

Device Count : 500

Ortho FlexTech - D798SSOFT0 Catalog Number : SSOFT

Device Description : Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.

Device Class : 1

Duns Number: 113170088

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Ortho FlexTech - D798SSOFTE0 Catalog Number : SSOFTE

Device Description : Stainless Steel Ortho FlexTech Dental Retention System is intended for use as a Stainless Steel Ortho FlexTech Dental Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel Etched version.

Device Class : 1

Duns Number: 113170088

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Ortho FlexTech - D798SSOFTSAM0 Catalog Number : SSOFT

Device Class : 1

Duns Number: 113170088

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Ortho FlexTech - D798SSOFTSAMETCHED0 Catalog Number : SSOFTSAMETCHED

Device Class : 1

Duns Number: 113170088

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Therma Cure - D798TC0 Catalog Number : TC

Device Description : Therma-Cure is intended for use as a heat curable adhesive for indirect bonding.

Device Class : 2

Duns Number: 113170088

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Tips - D798TIPS51 Catalog Number : TIPS5

Device Description : 15 gauge, light impervious tips designed to dispense flowable, light cure adhesives.

Device Class :

Duns Number: 113170088

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : Yes

Device Count : 5

TKO - D798TKOP0 Catalog Number :

Device Description : Composite Bite Turbo Gel Pink - Contains one 3.4g syringe with 5 tips

Device Class : 2

Duns Number: 113170088

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Assure Plus - D798UAP1 Catalog Number : UAPSAM

Device Description : Assure Plus resin is intended to increase adhesion to normal, atypical (wet or d Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed,deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth.This is a Unidose dispensing system.

Device Class :

Duns Number: 113170088

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 2

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