Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SRGC-06

K-Number: K261246 · 2026-06-18

ApplicantGC America, Inc.
Decision Date2026-06-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SRGC-06 is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K261246. 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 SRGC-06?

SRGC-06 is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is GC America, Inc.. The 510(k) number is K261246.

When did SRGC-06 receive FDA 510(k) clearance?

SRGC-06 received FDA 510(k) clearance on 2026-06-18, under 510(k) number K261246.

Who is the listed applicant for SRGC-06?

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

What is the FDA product code for SRGC-06?

The FDA product code for SRGC-06 is EBF.

Other records listing GC America, Inc. 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.

K253317Cytrans™ ElashieldK254109G-CEM UNIVERSALK251124G-Bond UniversalK250953EQUIA LC ONEK251946G aenial Universal Injectable IIK200798G-CEM ONE

View all 24 devices →

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.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.K261357Grandio disc multicolorVoco GmbH

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.

↑