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FDA 510(k)

SEPTOPACK TEMPORARY FILLING

K-Number: K915466 · 1992-02-03

ApplicantSpecialites Septodont
Decision Date1992-02-03
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEPTOPACK TEMPORARY FILLING is the device name listed in this FDA 510(k) record. The listed applicant is Specialites Septodont. It received FDA 510(k) clearance on 1992-02-03 under 510(k) number K915466. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEPTOPACK TEMPORARY FILLING?

SEPTOPACK TEMPORARY FILLING is a medical device that received FDA 510(k) clearance on 1992-02-03. The listed applicant is Specialites Septodont. The 510(k) number is K915466.

When did SEPTOPACK TEMPORARY FILLING receive FDA 510(k) clearance?

SEPTOPACK TEMPORARY FILLING received FDA 510(k) clearance on 1992-02-03, under 510(k) number K915466.

Who is the listed applicant for SEPTOPACK TEMPORARY FILLING?

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

What is the FDA product code for SEPTOPACK TEMPORARY FILLING?

The FDA product code for SEPTOPACK TEMPORARY FILLING is EBG.

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Other records listing Specialites Septodont 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.

K012427PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENTK010415ISODANK982773QUICKSET LIQUID AND POWDERK982671SECURALLOYK980633ENDOSOLV EK920692SEPTOCALCINE ULTRA

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Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials 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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