Crest Glide Clinical Gum Protection Dental Floss

FDA 510(k) K091964 · Procter & Gamble Co.

Substantially Equivalent

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

Official FDA 510(k) record

Device classification

Product code
JES – Floss, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.6390
Specialty
Dental

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K964976Flossbrush with FluorideJES · Traditional Flossbrush Interdental Cleaner and Applicator05/06/1997SE
K963746Ids Dental Floss with Sodium Fluoride Microdent Dental Floss with Sodium Fluoride AP-24…JES · Traditional Whitehill Oral Technologies, Inc.12/12/1996SE
K944034Perio-Med Dental FlossJES · Traditional Whitehill Oral Technologies, Inc.07/25/1995SE
K952091Vutler G.U.M. with FluorideJES · Traditional John O. Butler Co.06/28/1995SE
K951917Johnson & Johnson Easy Slide Dental FlossJES · Traditional Johnson & Johnson Consumer Products, Inc.05/10/1995SE
K944886Colgate Precision Mint Wzxed Dental FlossJES · Traditional Colgate-Palmolive Co.04/27/1995SE
K943157Oral-B Ultrafloss with FlluorideJES · Traditional Oral-B Laboratories04/27/1995SE
K942690Ranir Dental Tape Mint Waxed with FluorideJES · Traditional Ranir/Dcp Corp.04/27/1995SE
K942689Ranir Dental Floss Mint Waxed with FluorideJES · Traditional Ranir/Dcp Corp.04/27/1995SE
K935440Johnson & Johnson Fluoride Dental Floss, Mint WaxedJES · Traditional Johnson & Johnson Consumer Products, Inc.02/03/1994SE

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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.