Denshield Treatment for Sensitive Teeth
FDA 510(k) K061359 · Novamin Technology, Inc.
510(k) numberK061359
Submission
- Device name
- Denshield Treatment for Sensitive Teeth
- Applicant
- Novamin Technology, Inc.
Alachua, FL, US - Received
- May 16, 2006
- Decision date
- October 18, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
| K040858 | Oralief Therapy for Sensitive TeethLBH · Traditional | 09/02/2004SE |
| K041371 | Butler Nucare Prophylaxis Paste with NovaminEJR · Traditional | 08/23/2004SE |
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Questions and answers
When was Denshield Treatment for Sensitive Teeth cleared by the FDA?
Denshield Treatment for Sensitive Teeth (K061359) received a 510(k) decision of Substantially Equivalent on October 18, 2006, 155 days after the submission was received.
What is the product code of K061359?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.