FDA.reportPublic FDA data

510(k) K230445

Device
OnX Tough
Applicant
Sprintray, Inc.
510(k) number
K230445
Product code
EBI
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-14
Date received
2023-02-21
Regulation
872.3760
Classification name
Resin, Denture, Relining, Repairing, Rebasing
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sara Moghtadernejad
Address
2705 Media Center Dr., Suite 100a Los Angeles CA US 90065 90065

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260376Denture BaseShandong Huge Dental Material Corporation2026-05-06
K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.2025-11-25
K253681TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)Graphy, Inc.2025-11-21
K253324UltraPrint-Dental Denture UVGuangzhou Heygears IMC., Inc.2025-11-20
K252430Freeprint® denture flexDetax GmbH2025-10-30
K252035DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)Kamemizu Chemical Industry Co., Ltd.2025-09-17
K250302Flexible Partial ResinPrismatik Dentalcraft, Inc.2025-06-25
K242897Partial FlexClemde SA DE CV2025-06-03
K250489FP3DKeystone Industries2025-05-20
K250617Apex FlexSprintray, Inc.2025-04-29
K243356Asiga DentaBASEAsiga Pty, Ltd.2025-04-11
K250946Denture Base Resin DT20Hangzhou SHINING3D Dental Technology Co., Ltd.2025-03-31
K243103Denture BaseRiton 3D Technology Co., Ltd.2024-12-23
K243336Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc.2024-12-17
K242884Additively Manufactured Denture ResinAidite (Qinhuangdao) Technology Co., Ltd.2024-11-22