Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014289665

FEI Number

3014289665

Entity Name

SPRINTRAY INC.

City/State/Country

Los Angeles, CA, US

Establishment Address

2710, 2705 Media Center Dr Suite #100A, Los Angeles, CA 90065, US

Establishment Type(s)

Manufacture Medical Device

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Precision Guide Surgical Guide 3 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) Retainer Digital Temp (A1, A2, B1, Bleach) Apex Flex - Standard Pink Apex Flex - Light Pink NightGuard Flex 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) Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) SprintRay Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) Standard Denture Base (Light Pink, Original Pink, Dark Pink, Light Meharry, Original Meharry, Dark Meharry) Midas Restore (A1, A2, A3, B1, Bleach, Unpigmented, C2) Try-In 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2019-02-01
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2021-08-24
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2024-09-19
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2024-12-02
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2025-06-25
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2021-11-15
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2021-11-15
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-11-15
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
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-09-19
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
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2019-02-01

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
3024749697	SPRINTRAY INC.	Huntington Beach, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
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

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 3014289665. Last updated year: 2026. Please use registration number 3014289665 when referencing this establishment in official correspondence.