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FDA 510(k)

PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT

K-Number: K881890 · 1988-07-15

ApplicantSpecialites Septodont
Decision Date1988-07-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Specialites Septodont. It received FDA 510(k) clearance on 1988-07-15 under 510(k) number K881890. 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 PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT?

PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT is a medical device that received FDA 510(k) clearance on 1988-07-15. The listed applicant is Specialites Septodont. The 510(k) number is K881890.

When did PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT receive FDA 510(k) clearance?

PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT received FDA 510(k) clearance on 1988-07-15, under 510(k) number K881890.

Who is the listed applicant for PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT?

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 PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT?

The FDA product code for PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT is EMA.

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Other records listing Specialites Septodont as applicant

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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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