Vutler G.U.M. with Fluoride
FDA 510(k) K952091 · John O. Butler Co.
510(k) numberK952091
Submission
- Device name
- Vutler G.U.M. with Fluoride
- Applicant
- John O. Butler Co.
Chicago, IL, US - Received
- May 3, 1995
- Decision date
- June 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JES
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091964 | Crest Glide Clinical Gum Protection Dental FlossJES · Traditional | Procter & Gamble Co. | 09/24/2009SE |
| K964976 | Flossbrush with FluorideJES · Traditional | Flossbrush Interdental Cleaner and Applicator | 05/06/1997SE |
| K963746 | Ids Dental Floss with Sodium Fluoride Microdent Dental Floss with Sodium Fluoride AP-24…JES · Traditional | Whitehill Oral Technologies, Inc. | 12/12/1996SE |
| K944034 | Perio-Med Dental FlossJES · Traditional | Whitehill Oral Technologies, Inc. | 07/25/1995SE |
| K951917 | Johnson & Johnson Easy Slide Dental FlossJES · Traditional | Johnson & Johnson Consumer Products, Inc. | 05/10/1995SE |
| K944886 | Colgate Precision Mint Wzxed Dental FlossJES · Traditional | Colgate-Palmolive Co. | 04/27/1995SE |
| K943157 | Oral-B Ultrafloss with FlluorideJES · Traditional | Oral-B Laboratories | 04/27/1995SE |
| K942690 | Ranir Dental Tape Mint Waxed with FluorideJES · Traditional | Ranir/Dcp Corp. | 04/27/1995SE |
| K942689 | Ranir Dental Floss Mint Waxed with FluorideJES · Traditional | Ranir/Dcp Corp. | 04/27/1995SE |
| K935440 | Johnson & Johnson Fluoride Dental Floss, Mint WaxedJES · Traditional | Johnson & Johnson Consumer Products, Inc. | 02/03/1994SE |
More from Johnson & Johnson Consumer Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K022900 | Butler Gum Vari-Clean Power ToothbrushesJEQ · Traditional | 11/14/2002SE |
| K974761 | Butler Antibacterial Interdental ToothbrushEFW · Traditional | 06/16/1998SE |
| K950993 | Butler G.U.M. Antibacterial ToothbrushEFW · Traditional | 06/02/1995SE |
| K943942 | Trav-Ler KitJEQ · Traditional | 03/08/1995SESK |
| K874194 | Protect Drops/Same AS K874070EJK · Traditional | 12/16/1987SE |
Questions and answers
When was Vutler G.U.M. with Fluoride cleared by the FDA?
Vutler G.U.M. with Fluoride (K952091) received a 510(k) decision of Substantially Equivalent on June 28, 1995, 56 days after the submission was received.
What is the product code of K952091?
The FDA product code is JES – Floss, Dental, a Class I (low risk) device regulated under 21 CFR 872.6390.