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FDA 510(k)

OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT

K-Number: K801779 · 1980-08-07

ApplicantOxy Dental Products, Inc.
Decision Date1980-08-07
Product CodeEMB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Oxy Dental Products, Inc.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801779. The device is classified under product code EMB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT?

OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is Oxy Dental Products, Inc.. The 510(k) number is K801779.

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

OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801779.

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

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

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

The FDA product code for OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT is EMB.

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Other records listing Oxy Dental Products, 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.

K801780OXY CUSTOM TRAY RESIN

Related Devices (Code: EMB)

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.

K161630Provicol QM PlusVoco GmbHK120695DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KITDentist IN A Box Pty., Ltd.K110759TEMPOCEMDmg USA, Inc.K073539PROVISA CEMCavex Holland BVK020158NON-EUGENOL TEMPORARY CEMENTJ. Morita USA, Inc.K941066DENTAL 911L.A.F. Industries, 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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