Crest Glide Clinical Gum Protection Dental Floss
FDA 510(k) K091964 · Procter & Gamble Co.
510(k) numberK091964
Submission
- Device name
- Crest Glide Clinical Gum Protection Dental Floss
- Applicant
- Procter & Gamble Co.
Mason, OH, US - Received
- July 1, 2009
- Decision date
- September 24, 2009
- 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 |
|---|---|---|---|
| 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 |
| K935440 | Johnson & Johnson Fluoride Dental Floss, Mint WaxedJES · Traditional | Johnson & Johnson Consumer Products, Inc. | 02/03/1994SE |
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| K133244 | Tampax M Plastic Tampons, UnscentedHEB · Special | 01/09/2014SE |
| K131543 | Tampax(R) L Plastic Tampons, UnscentedHEB · Special | 06/20/2013SE |
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Questions and answers
When was Crest Glide Clinical Gum Protection Dental Floss cleared by the FDA?
Crest Glide Clinical Gum Protection Dental Floss (K091964) received a 510(k) decision of Substantially Equivalent on September 24, 2009, 85 days after the submission was received.
What is the product code of K091964?
The FDA product code is JES – Floss, Dental, a Class I (low risk) device regulated under 21 CFR 872.6390.