SprintRay High Impact Denture Base
FDA 510(k) K221678 · Sprintray, Inc.
510(k) numberK221678
Submission
- Device name
- SprintRay High Impact Denture Base
- Applicant
- Sprintray, Inc.
Los Angeles, CA, US - Received
- June 9, 2022
- Decision date
- November 10, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253365 | LuxCreo Flexible Partial Denture ResinEBI · Traditional | LuxCreo, Inc. | 11/25/2025SE |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard…EBI · Traditional | Graphy, Inc. | 11/21/2025SE |
| K253324 | UltraPrint-Dental Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 11/20/2025SE |
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| K230445 | OnX ToughEBI · Traditional | 07/14/2023SE |
| K222623 | Digital CrownEBF · Traditional | 12/14/2022SE |
| K220979 | SprintRay Denture BaseEBI · Traditional | 09/14/2022SE |
| K212448 | NightGuard FlexMQC · Traditional | 11/12/2021SE |
Questions and answers
When was SprintRay High Impact Denture Base cleared by the FDA?
SprintRay High Impact Denture Base (K221678) received a 510(k) decision of Substantially Equivalent on November 10, 2022, 154 days after the submission was received.
What is the product code of K221678?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.