Butler G.U.M. Antibacterial Toothbrush
FDA 510(k) K950993 · John O. Butler
510(k) numberK950993
Submission
- Device name
- Butler G.U.M. Antibacterial Toothbrush
- Applicant
- John O. Butler
Chicago, IL, US - Received
- March 3, 1995
- Decision date
- June 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130186 | Dentek Easy Brush with FluorideEFW · Traditional | Den Tek Oral Care, Inc. | 07/15/2013SE |
| K121165 | Beam Brush/Beam AppEFW · Traditional | Beam Technologies, LLC | 06/21/2012SE |
| K102871 | Silver Care Anitbacterial ToothbrushEFW · Traditional | Piave Spazzolificio S.P.A. | 10/03/2011SE |
| K073224 | Oral-B Sub-Brand Manual ToothbrushEFW · Traditional | Procter & Gamble | 02/06/2008SE |
| K021383 | Zeodyne Toothbrush with Agion AntimicrobialEFW · Traditional | Agion Technologies, LLC | 07/17/2002SE |
| K020776 | Medoral Hygienic Toothbrush with Dentosan FilamentsEFW · Traditional | Coronet Group North America, LLC | 06/03/2002SE |
| K000290 | Lazersmile, LazerwhiteEFW · Traditional | Biolase Technology, Inc. | 04/14/2000SE |
| K994144 | Toothbrush WashEFW · Traditional | Cal Huech, Inc. | 03/02/2000SE |
| K992435 | Bacti-Stop Toothbrush Cleaner and SanitizerEFW · Traditional | Azo Enterprises | 10/15/1999SE |
| K980995 | Plaq-Ataq-IEFW · Traditional | Ethicare | 08/20/1998SE |
More from Ethicare
| 510(k) | Device | Decision |
|---|---|---|
| K022900 | Butler Gum Vari-Clean Power ToothbrushesJEQ · Traditional | 11/14/2002SE |
| K974761 | Butler Antibacterial Interdental ToothbrushEFW · Traditional | 06/16/1998SE |
| K952091 | Vutler G.U.M. with FluorideJES · Traditional | 06/28/1995SE |
| K943942 | Trav-Ler KitJEQ · Traditional | 03/08/1995SESK |
| K874194 | Protect Drops/Same AS K874070EJK · Traditional | 12/16/1987SE |
Questions and answers
When was Butler G.U.M. Antibacterial Toothbrush cleared by the FDA?
Butler G.U.M. Antibacterial Toothbrush (K950993) received a 510(k) decision of Substantially Equivalent on June 2, 1995, 91 days after the submission was received.
What is the product code of K950993?
The FDA product code is EFW – Toothbrush, Manual, a Class I (low risk) device regulated under 21 CFR 872.6855.