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)

BOSWORTH AIR POLISHER

K-Number: K100731 · 2010-12-03

ApplicantHarry J. Bosworth Co.
Decision Date2010-12-03
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BOSWORTH AIR POLISHER is the device name listed in this FDA 510(k) record. The listed applicant is Harry J. Bosworth Co.. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K100731. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSWORTH AIR POLISHER?

BOSWORTH AIR POLISHER is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Harry J. Bosworth Co.. The 510(k) number is K100731.

When did BOSWORTH AIR POLISHER receive FDA 510(k) clearance?

BOSWORTH AIR POLISHER received FDA 510(k) clearance on 2010-12-03, under 510(k) number K100731.

Who is the listed applicant for BOSWORTH AIR POLISHER?

The FDA 510(k) record lists Harry J. Bosworth Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSWORTH AIR POLISHER?

The FDA product code for BOSWORTH AIR POLISHER is EFB.

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 Harry J. Bosworth 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.

K103585BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACPK061611BOSWORTH DENTIN RESINK051224BOSWORTH SEALK043170BOSWORTH BONDK040548AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVEK040547AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE

View all 45 devices →

Related Devices (Code: EFB)

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.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.

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.

↑