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FDA 510(k)

SprintRay High Impact Denture Base

K-Number: K221678 · 2022-11-10

ApplicantSprintray, Inc.
Decision Date2022-11-10
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SprintRay High Impact Denture Base is the device name listed in this FDA 510(k) record. The listed applicant is Sprintray, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K221678. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SprintRay High Impact Denture Base?

SprintRay High Impact Denture Base is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Sprintray, Inc.. The 510(k) number is K221678.

When did SprintRay High Impact Denture Base receive FDA 510(k) clearance?

SprintRay High Impact Denture Base received FDA 510(k) clearance on 2022-11-10, under 510(k) number K221678.

Who is the listed applicant for SprintRay High Impact Denture Base?

The FDA 510(k) record lists Sprintray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SprintRay High Impact Denture Base?

The FDA product code for SprintRay High Impact Denture Base is EBI.

Other records listing Sprintray, Inc. as applicant

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Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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