Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024749697

FEI Number

3024749697

Entity Name

SPRINTRAY INC.

City/State/Country

Huntington Beach, CA, US

Establishment Address

17601 Sampson Ln., Huntington Beach, CA 92647, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SprintRay Inc. (Owner Number: 10059580)

Owner / Operator Contact Address

17601 Sampson Ln., Huntington Beach, CA 92647, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250617

PMA Number

N/A

All Registered Proprietary Names

Retainer Precision Guide Surgical Guide 3 Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) SprintRay Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) NightGuard Flex Standard Denture Teeth (A1, A2, A3, B1) NanoCeramic Hybrid OnX (Bleach, A1, B1) Apex Teeth (A1, A2, B1, Bleach) High Impact Denture Teeth (Bleach, A1, A2, A3, B1) OnX Tough (Hollywood Bleach) OnX Tough 2 (Bleach, A1, A2, B1, Hollywood White) Crown HT (A1, A2, A3, B1, Unpigmented, Bleach) Midas Restore (A1, A2, A3, B1, Bleach, Unpigmented, C2) Digital Temp (A1, A2, B1, Bleach) NightGuard Firm NightGuard Flex 2 (Simply Clear, Ocean Blue) NightGuard Firm 2 (Midnight Purple) Standard Denture Base (Light Pink, Original Pink, Dark Pink, Light Meharry, Original Meharry, Dark Meharry) Apex Base (Light Pink, Original Pink, Dark Reddish Pink, Opaque Original Pink) High Impact Denture Base (Light Pink, Original Pink, Dark Pink, Light Meharry, Original Meharry, Bubblegum) Apex Flex - Standard Pink Apex Flex - Light Pink

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2024-09-19
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2019-02-01
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-12-28
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-12-28
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2022-12-28
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2021-11-15
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2021-11-15
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2021-08-24
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2023-07-18
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2023-07-18
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2024-12-02
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2024-12-02
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2024-12-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-12-02
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2024-12-02
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2026-05-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-05-26
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2024-12-02
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2023-04-20
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-09-19
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-11-15
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2025-06-25

Official Correspondent

Sara Moghtadernejad

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SprintRay Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014289665	SPRINTRAY INC.	Los Angeles, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024749697. Last updated year: 2026. Please use registration number 3024749697 when referencing this establishment in official correspondence.