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)

SMARTBURS

K-Number: K080687 · 2008-06-20

ApplicantS.S. White Burs, Inc.
Decision Date2008-06-20
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMARTBURS is the device name listed in this FDA 510(k) record. The listed applicant is S.S. White Burs, Inc.. It received FDA 510(k) clearance on 2008-06-20 under 510(k) number K080687. 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 SMARTBURS?

SMARTBURS is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is S.S. White Burs, Inc.. The 510(k) number is K080687.

When did SMARTBURS receive FDA 510(k) clearance?

SMARTBURS received FDA 510(k) clearance on 2008-06-20, under 510(k) number K080687.

Who is the listed applicant for SMARTBURS?

The FDA 510(k) record lists S.S. White Burs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTBURS?

The FDA product code for SMARTBURS 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

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.

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.K921406SILICONT BUR BLOCKInnovators, 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.

↑