Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DENTAL ROTARY CARBIDE BURS 76EJL

K-Number: K780641 · 1978-04-21

ApplicantTeledyne Densco
Decision Date1978-04-21
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL ROTARY CARBIDE BURS 76EJL is the device name listed in this FDA 510(k) record. The listed applicant is Teledyne Densco. It received FDA 510(k) clearance on 1978-04-21 under 510(k) number K780641. The device is classified under product code EJL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL ROTARY CARBIDE BURS 76EJL?

DENTAL ROTARY CARBIDE BURS 76EJL is a medical device that received FDA 510(k) clearance on 1978-04-21. The listed applicant is Teledyne Densco. The 510(k) number is K780641.

When did DENTAL ROTARY CARBIDE BURS 76EJL receive FDA 510(k) clearance?

DENTAL ROTARY CARBIDE BURS 76EJL received FDA 510(k) clearance on 1978-04-21, under 510(k) number K780641.

Who is the listed applicant for DENTAL ROTARY CARBIDE BURS 76EJL?

The FDA 510(k) record lists Teledyne Densco as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL ROTARY CARBIDE BURS 76EJL?

The FDA product code for DENTAL ROTARY CARBIDE BURS 76EJL is EJL.

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 Teledyne Densco 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.

K821686DENSCO PROPHY ANGLEK821364PROFLEX FLEXIBLE SCALERK803155PROPHYLAXIS CUP.

Related Devices (Code: EJL)

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.

K080687SMARTBURSS.S. White Burs, Inc.K071352CERADRILLGebr. Brasseler GmbH & Co. KGK061383BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPSB.T.I. Biotechnology Institute, Sl.K943273TRI HAWK BUR, FG BURTri Hawk Corp.K926205MONOSTERYLUtensili Super AbrasiviK923883DENTAL OR SURGICAL BURStratum Dental Technologies, 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.

↑