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FDA 510(k)

ZINC OXIDE EUGENOL TEMPORARY CEMENT

K-Number: K883698 · 1988-11-29

ApplicantE&D Dental Manufacturing Co.
Decision Date1988-11-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZINC OXIDE EUGENOL TEMPORARY CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is E&D Dental Manufacturing Co.. It received FDA 510(k) clearance on 1988-11-29 under 510(k) number K883698. 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 ZINC OXIDE EUGENOL TEMPORARY CEMENT?

ZINC OXIDE EUGENOL TEMPORARY CEMENT is a medical device that received FDA 510(k) clearance on 1988-11-29. The listed applicant is E&D Dental Manufacturing Co.. The 510(k) number is K883698.

When did ZINC OXIDE EUGENOL TEMPORARY CEMENT receive FDA 510(k) clearance?

ZINC OXIDE EUGENOL TEMPORARY CEMENT received FDA 510(k) clearance on 1988-11-29, under 510(k) number K883698.

Who is the listed applicant for ZINC OXIDE EUGENOL TEMPORARY CEMENT?

The FDA 510(k) record lists E&D Dental Manufacturing Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZINC OXIDE EUGENOL TEMPORARY CEMENT?

The FDA product code for ZINC OXIDE EUGENOL TEMPORARY CEMENT is EMA.

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Other records listing E&D Dental Manufacturing Co. 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.

K873739ACRYLIC IMPRESSION TRAY MATERIALSK873738ACRYLIC BASE DENTURE MATERIALSK871639DENTAL DIAMOND BURSK864922DENTAL HANDPIECES AND ATTACHMENTK862745EUGENOL USP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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