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FDA 510(k)

DENTAL DIAMOND BURS

K-Number: K871639 · 1987-05-18

ApplicantE&D Dental Manufacturing Co.
Decision Date1987-05-18
Product CodeDZP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL DIAMOND BURS 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 1987-05-18 under 510(k) number K871639. The device is classified under product code DZP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL DIAMOND BURS?

DENTAL DIAMOND BURS is a medical device that received FDA 510(k) clearance on 1987-05-18. The listed applicant is E&D Dental Manufacturing Co.. The 510(k) number is K871639.

When did DENTAL DIAMOND BURS receive FDA 510(k) clearance?

DENTAL DIAMOND BURS received FDA 510(k) clearance on 1987-05-18, under 510(k) number K871639.

Who is the listed applicant for DENTAL DIAMOND BURS?

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 DENTAL DIAMOND BURS?

The FDA product code for DENTAL DIAMOND BURS is DZP.

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 MATERIALSK864922DENTAL HANDPIECES AND ATTACHMENTK862745EUGENOL USP

Related Devices (Code: DZP)

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.

K120037BLUWHITE DIAMOND DENTAL BURS MODIFIEDBeavers Dental, Div. Sybron Canada, Ltd.K943841SOPHOS DENTAL DIAMONDSophos TechnologicK940908DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURSDunhall Pharmaceuticals, Inc.K934981DENTAL DRILLEare Consulting ServiceK923757DENTAL DIAMOND DRILLSAlpha Industrializacao DE Metais Ltda.K913651MANI DIA-BURSThe Lahr Consulting Group, 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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