Ranir Dental Tape Mint Waxed with Fluoride

FDA 510(k) K942690 · Ranir/Dcp Corp.

Substantially Equivalent

510(k) numberK942690

Submission

Device name
Ranir Dental Tape Mint Waxed with Fluoride
Applicant
Ranir/Dcp Corp.
Grand Rapids, MI, US
Received
June 7, 1994
Decision date
April 27, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

Other 510(k)s with product code JES

510(k)DeviceApplicantDecision
K091964Crest Glide Clinical Gum Protection Dental FlossJES · Traditional Procter & Gamble Co.09/24/2009SE
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
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

More from Johnson & Johnson Consumer Products, Inc.

510(k)DeviceDecision
K955530Ranir Hi-Technology Dental FlossEFW · Traditional 12/28/1995SE
K942689Ranir Dental Floss Mint Waxed with FluorideJES · Traditional 04/27/1995SE
K935906Ranir Plax RXEAX · Traditional 09/02/1994SE
K935522Ranir Dental Tape Mint Waxed with FlourideJES · Traditional 01/26/1994SE
K924739The Dentist's Tooth PolisherJEQ · Traditional 11/24/1992SE

Questions and answers

When was Ranir Dental Tape Mint Waxed with Fluoride cleared by the FDA?

Ranir Dental Tape Mint Waxed with Fluoride (K942690) received a 510(k) decision of Substantially Equivalent on April 27, 1995, 324 days after the submission was received.

What is the product code of K942690?

The FDA product code is JES – Floss, Dental, a Class I (low risk) device regulated under 21 CFR 872.6390.