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)

BURR, DENTAL

K-Number: K801886 · 1980-08-20

ApplicantAesculap Instruments Corp.
Decision Date1980-08-20
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BURR, DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Instruments Corp.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801886. 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 BURR, DENTAL?

BURR, DENTAL is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Aesculap Instruments Corp.. The 510(k) number is K801886.

When did BURR, DENTAL receive FDA 510(k) clearance?

BURR, DENTAL received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801886.

Who is the listed applicant for BURR, DENTAL?

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

What is the FDA product code for BURR, DENTAL?

The FDA product code for BURR, DENTAL 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 Aesculap Instruments Corp. 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.

K885046INSITUCAT VALVE STRIPPERK890182PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DVK890443CASPAR SCALP CLIP, APPLIERK893121ROBOTRAC (TM) RETRACTOR ARMK884057ELAN-E DISPOSABLE DRAPEK880704CERULLO SUCTION REGULATOR

View all 13 devices →

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.

↑