Ranir Hi-Technology Dental Floss
FDA 510(k) K955530 · Ranir/Dcp Corp.
510(k) numberK955530
Submission
- Device name
- Ranir Hi-Technology Dental Floss
- Applicant
- Ranir/Dcp Corp.
Grand Rapids, MI, US - Received
- December 4, 1995
- Decision date
- December 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K000290 | Lazersmile, LazerwhiteEFW · Traditional | Biolase Technology, Inc. | 04/14/2000SE |
| K994144 | Toothbrush WashEFW · Traditional | Cal Huech, Inc. | 03/02/2000SE |
| K992435 | Bacti-Stop Toothbrush Cleaner and SanitizerEFW · Traditional | Azo Enterprises | 10/15/1999SE |
| K980995 | Plaq-Ataq-IEFW · Traditional | Ethicare | 08/20/1998SE |
More from Ethicare
| 510(k) | Device | Decision |
|---|---|---|
| K942690 | Ranir Dental Tape Mint Waxed with FluorideJES · Traditional | 04/27/1995SE |
| K942689 | Ranir Dental Floss Mint Waxed with FluorideJES · Traditional | 04/27/1995SE |
| K935906 | Ranir Plax RXEAX · Traditional | 09/02/1994SE |
| K935522 | Ranir Dental Tape Mint Waxed with FlourideJES · Traditional | 01/26/1994SE |
| K924739 | The Dentist's Tooth PolisherJEQ · Traditional | 11/24/1992SE |
Questions and answers
When was Ranir Hi-Technology Dental Floss cleared by the FDA?
Ranir Hi-Technology Dental Floss (K955530) received a 510(k) decision of Substantially Equivalent on December 28, 1995, 24 days after the submission was received.
What is the product code of K955530?
The FDA product code is EFW – Toothbrush, Manual, a Class I (low risk) device regulated under 21 CFR 872.6855.