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FDA 510(k)

AUTOPACK NON-EUGENOL PERIODONTAL DRESSING

K-Number: K913572 · 1991-10-09

ApplicantSpecialites Septodont
Decision Date1991-10-09
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUTOPACK NON-EUGENOL PERIODONTAL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Specialites Septodont. It received FDA 510(k) clearance on 1991-10-09 under 510(k) number K913572. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOPACK NON-EUGENOL PERIODONTAL DRESSING?

AUTOPACK NON-EUGENOL PERIODONTAL DRESSING is a medical device that received FDA 510(k) clearance on 1991-10-09. The listed applicant is Specialites Septodont. The 510(k) number is K913572.

When did AUTOPACK NON-EUGENOL PERIODONTAL DRESSING receive FDA 510(k) clearance?

AUTOPACK NON-EUGENOL PERIODONTAL DRESSING received FDA 510(k) clearance on 1991-10-09, under 510(k) number K913572.

Who is the listed applicant for AUTOPACK NON-EUGENOL PERIODONTAL DRESSING?

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 AUTOPACK NON-EUGENOL PERIODONTAL DRESSING?

The FDA product code for AUTOPACK NON-EUGENOL PERIODONTAL DRESSING is EMA.

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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: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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