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FDA 510(k)

BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH

K-Number: K950993 · 1995-06-02

ApplicantJohn O. Butler
Decision Date1995-06-02
Product CodeEFW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH is the device name listed in this FDA 510(k) record. The listed applicant is John O. Butler. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K950993. The device is classified under product code EFW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH?

BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is John O. Butler. The 510(k) number is K950993.

When did BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH receive FDA 510(k) clearance?

BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH received FDA 510(k) clearance on 1995-06-02, under 510(k) number K950993.

Who is the listed applicant for BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH?

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

What is the FDA product code for BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH?

The FDA product code for BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH is EFW.

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 John O. Butler 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.

K874194PROTECT DROPS/SAME AS K874070

Related Devices (Code: EFW)

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.

K130186DENTEK EASY BRUSH WITH FLUORIDEDen Tek Oral Care, Inc.K121165BEAM BRUSH/BEAM APPBeam Technologies, LLCK102871SILVER CARE ANITBACTERIAL TOOTHBRUSHPiave Spazzolificio S.P.A.K073224ORAL-B SUB-BRAND MANUAL TOOTHBRUSHProcter & GambleK021383ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIALAgion Technologies, LLCK020776MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTSCoronet Group North America, LLC

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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