Colgate Dental Floss
FDA 510(k) K883335 · Colgate-Palmolive Co.
510(k) numberK883335
Submission
- Device name
- Colgate Dental Floss
- Applicant
- Colgate-Palmolive Co.
Piscataway, NJ, US - Received
- August 9, 1988
- Decision date
- August 26, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K952091 | Vutler G.U.M. with FluorideJES · Traditional | John O. Butler Co. | 06/28/1995SE |
| 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 |
More from Ranir/Dcp Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K140481 | Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief MouthwashLBH · Traditional | 06/05/2014SE |
| K103461 | Colgate Desensitizing Dental CreamLBH · Traditional | 09/13/2011SE |
| K944886 | Colgate Precision Mint Wzxed Dental FlossJES · Traditional | 04/27/1995SE |
| K901955 | Periogard(R) PeriopenEFS · Traditional | 04/15/1991SE |
Questions and answers
When was Colgate Dental Floss cleared by the FDA?
Colgate Dental Floss (K883335) received a 510(k) decision of Substantially Equivalent on August 26, 1988, 17 days after the submission was received.
What is the product code of K883335?
The FDA product code is JES – Floss, Dental, a Class I (low risk) device regulated under 21 CFR 872.6390.