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) (4) Additively Manufactured, Preformed, Resin Denture Tooth (PZY) (3) Denture, Plastic, Teeth (ELM) (3) Teeth, Artificial, Posterior With Metal Insert (ELJ) (3) Teeth, Artificial, Backing And Facing (ELK) (3) Accessories, Implant, Dental, Endosseous (NDP) (2) Mouthguard, Prescription (MQC) (1) Positioner, Tooth, Preformed (KMY) (1) Indirect Bonding Tray (QJJ) (1)

Premarket Exempt

No Yes

Clear

Surgical Guide 2 - 00850039704024 Catalog Number : SRI-0205005

Device Description : Intended to be used for fabrication of surgical guide

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Surgical Guide 3 - 00850039704031 Catalog Number : SRI-0205011

Device Description : Intended to be used for fabrication of surgical guide

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Gingiva Mask - 00850039704048 Catalog Number : SRI-0202028

Device Description : Indicated for the fabrication, by additive manufacturing, of gingival replica fo

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

IDB 2 - 00850039704055 Catalog Number : SRI-0202012

Device Description : Indicated for the fabrication, by additive manufacturing, of Indirect Bonding Tray

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : QJJ, EBH

Prescription Use : Yes

Device Count : 1

NightGuard Flex - 00850039704062 Catalog Number : SRI-0202015

Device Description : Indicated for the fabrication of orthodontic and dental appliances such as mouth

Device Class : 1

Duns Number: 063005260

Premarket Exempt : No

Product Code : KMY, MQC

Prescription Use : Yes

Device Count : 1

OnX - Bleach - 00850039704079 Catalog Number : SRI-0202021

Device Description : Full arch provisional restoration for all-on-x cases. Denture teeth for removabl

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : PZY, ELM, ELK, ELJ

Prescription Use : Yes

Device Count : 1

OnX - A1 - 00850039704086 Catalog Number : SRI-0202027

Device Description : Full arch provisional restoration for all-on-x cases. Denture teeth for removabl

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : PZY, ELM, ELK, ELJ

Prescription Use : Yes

Device Count : 1

OnX - B1 - 00850039704093 Catalog Number : SRI-0202026

Device Description : Full arch provisional restoration for all-on-x cases. Denture teeth for removabl

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : PZY, ELM, ELK, ELJ

Prescription Use : Yes

Device Count : 1

Die and Model 2 (Tan) - 00850039704109 Catalog Number : SRI-0202010

Device Description : Intended to be used to fabricate teeth models, which can be used for multiple pu

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

Die and Model 2 (Gray) - 00850039704116 Catalog Number : SRI-0202011

Device Description : Intended to be used to fabricate teeth models, which can be used for multiple pu

Device Class : 1

Duns Number: 063005260

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

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