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FDA 510(k)

EUGENOL USP

K-Number: K862745 · 1986-07-31

ApplicantE&D Dental Manufacturing Co.
Decision Date1986-07-31
Product CodeEMB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EUGENOL USP 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 1986-07-31 under 510(k) number K862745. 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 EUGENOL USP?

EUGENOL USP is a medical device that received FDA 510(k) clearance on 1986-07-31. The listed applicant is E&D Dental Manufacturing Co.. The 510(k) number is K862745.

When did EUGENOL USP receive FDA 510(k) clearance?

EUGENOL USP received FDA 510(k) clearance on 1986-07-31, under 510(k) number K862745.

Who is the listed applicant for EUGENOL USP?

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 EUGENOL USP?

The FDA product code for EUGENOL USP is EMB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K883698ZINC OXIDE EUGENOL TEMPORARY CEMENTK873739ACRYLIC IMPRESSION TRAY MATERIALSK873738ACRYLIC BASE DENTURE MATERIALSK871639DENTAL DIAMOND BURSK864922DENTAL HANDPIECES AND ATTACHMENT

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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