Oralief Therapy for Sensitive Teeth
FDA 510(k) K040858 · Novamin Technology, Inc.
510(k) numberK040858
Submission
- Device name
- Oralief Therapy for Sensitive Teeth
- Applicant
- Novamin Technology, Inc.
Alachua, FL, US - Received
- April 2, 2004
- Decision date
- September 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Jasberry Healthcare Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K080228 | Oralief OTC Toothpaste for Sensitive TeethLBH · Traditional | 03/27/2008SE |
| K071267 | Periosrp Tooth Root Conditioner with NovaminLBH · Special | 05/18/2007SE |
| K061359 | Denshield Treatment for Sensitive TeethLBH · Traditional | 10/18/2006SE |
| K041371 | Butler Nucare Prophylaxis Paste with NovaminEJR · Traditional | 08/23/2004SE |
| K040473 | Oravive Tooth Revitalizing PasteLBH · Traditional | 03/10/2004SE |
| K033295 | Butler Nucare Root Conditioner with NovaminLBH · Traditional | 10/28/2003SE |
Questions and answers
When was Oralief Therapy for Sensitive Teeth cleared by the FDA?
Oralief Therapy for Sensitive Teeth (K040858) received a 510(k) decision of Substantially Equivalent on September 2, 2004, 153 days after the submission was received.
What is the product code of K040858?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.