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FDA 510(k)

Stela Capsule System

K-Number: K222583 · 2022-10-28

ApplicantSdi Limited
Decision Date2022-10-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stela Capsule System is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Limited. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K222583. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stela Capsule System?

Stela Capsule System is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Sdi Limited. The 510(k) number is K222583.

When did Stela Capsule System receive FDA 510(k) clearance?

Stela Capsule System received FDA 510(k) clearance on 2022-10-28, under 510(k) number K222583.

Who is the listed applicant for Stela Capsule System?

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

What is the FDA product code for Stela Capsule System?

The FDA product code for Stela Capsule System is EBF.

Other records listing Sdi Limited as applicant

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.

K222581Stela Automix SystemK214118Riva Cem AutomixK191656ZipbondK172047Riva Star

Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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