Butler Nucare Root Conditioner with Novamin
FDA 510(k) K033295 · Novamin Technology, Inc.
510(k) numberK033295
Submission
- Device name
- Butler Nucare Root Conditioner with Novamin
- Applicant
- Novamin Technology, Inc.
Alachua, FL, US - Received
- October 14, 2003
- Decision date
- October 28, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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|---|---|---|
| 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 |
| K040858 | Oralief Therapy for Sensitive TeethLBH · Traditional | 09/02/2004SE |
| K041371 | Butler Nucare Prophylaxis Paste with NovaminEJR · Traditional | 08/23/2004SE |
| K040473 | Oravive Tooth Revitalizing PasteLBH · Traditional | 03/10/2004SE |
Questions and answers
When was Butler Nucare Root Conditioner with Novamin cleared by the FDA?
Butler Nucare Root Conditioner with Novamin (K033295) received a 510(k) decision of Substantially Equivalent on October 28, 2003, 14 days after the submission was received.
What is the product code of K033295?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.