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FDA 510(k)

ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)

K-Number: K933543 · 1993-11-01

ApplicantJedental Co., Inc.
Decision Date1993-11-01
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) is the device name listed in this FDA 510(k) record. The listed applicant is Jedental Co., Inc.. It received FDA 510(k) clearance on 1993-11-01 under 510(k) number K933543. 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 ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)?

ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) is a medical device that received FDA 510(k) clearance on 1993-11-01. The listed applicant is Jedental Co., Inc.. The 510(k) number is K933543.

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

ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) received FDA 510(k) clearance on 1993-11-01, under 510(k) number K933543.

Who is the listed applicant for ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)?

The FDA 510(k) record lists Jedental Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)?

The FDA product code for ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) is EMA.

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Other records listing Jedental Co., Inc. 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.

K933612JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)K935718JEDENTAL VLC DENTAL CURING LIGHTK934073JEDENTAL GLASS IONOMER CEMENT AND LINERK935727P&FS PIT AND FISSURE SEALANTK933656JEDENTAL PSROFILL SELF-CURE COMPOSITEK933554JEDENTAL ZINC CEMENT IMPROVED

View all 8 devices →

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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