Sprintray, Inc.

Address:2705 & 2710 Media Center Dr Suite #100A,Los Angeles,CA,90065,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

Material, Impression Tray, Resin (EBH) (3) Additively Manufactured, Preformed, Resin Denture Tooth (PZY) (1) Denture, Plastic, Teeth (ELM) (1) Plate, Base, Shellac (EEA) (1) Teeth, Artificial, Backing And Facing (ELK) (1) Teeth, Artificial, Posterior With Metal Insert (ELJ) (1)

Premarket Exempt

No Yes

Clear

Die and Model 2 Pink - 00850039704123 Catalog Number : SRI-0202023

Device Description : Intended to be used to fabricate teeth models, which can be used for multiple pu Intended to be used to fabricate teeth models, which can be used for multiple purposes such as: Aligner model, Retainer model, Bleaching Tray model, Wax-Up model, Removable die model, impression tray.

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

Die and Model 2 Natural - 00850039704130 Catalog Number : SRI-0202022

Device Class :

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

Study Model White 2 - 00850039704147 Catalog Number : SRI-0202014

Device Description : Intended to be used to fabricate teeth models, which can be used for multiple pu Intended to be used to fabricate teeth models, which can be used for multiple purposes such as: Study model, Aligner model, Retainer model, Bleaching Tray model, Wax-up model, impression tray.

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

Try-In 2 - 00850039704154 Catalog Number : SRI-0202031

Device Description : Intended to be used to fabricate teeth models, which can be used for fabricating Intended to be used to fabricate teeth models, which can be used for fabricating Try-In Dentures for cosmetic and not masticatory purposes.

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : EEA

Prescription Use : Yes

Device Count : 1

OnX Tough - Hollywood Bleach - 00850039704178 Catalog Number : SRI-0202071

Device Description : The material is an alternative to traditional dental prostheses material. Sprint The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : PZY, ELM, ELK, ELJ

Prescription Use : Yes

Device Count : 1

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