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FDA 510(k)

ISODAN

K-Number: K010415 · 2001-07-23

ApplicantSpecialites Septodont
Decision Date2001-07-23
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ISODAN is the device name listed in this FDA 510(k) record. The listed applicant is Specialites Septodont. It received FDA 510(k) clearance on 2001-07-23 under 510(k) number K010415. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISODAN?

ISODAN is a medical device that received FDA 510(k) clearance on 2001-07-23. The listed applicant is Specialites Septodont. The 510(k) number is K010415.

When did ISODAN receive FDA 510(k) clearance?

ISODAN received FDA 510(k) clearance on 2001-07-23, under 510(k) number K010415.

Who is the listed applicant for ISODAN?

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 ISODAN?

The FDA product code for ISODAN is KLE.

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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 AGENTK982773QUICKSET LIQUID AND POWDERK982671SECURALLOYK980633ENDOSOLV EK920692SEPTOCALCINE ULTRAK915466SEPTOPACK TEMPORARY FILLING

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Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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