Oravive Tooth Revitalizing Paste
FDA 510(k) K040473 · Novamin Technology, Inc.
510(k) numberK040473
Submission
- Device name
- Oravive Tooth Revitalizing Paste
- Applicant
- Novamin Technology, Inc.
Alachua, FL, US - Received
- February 24, 2004
- Decision date
- March 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262243 | Profisil FreeLBH · Traditional | Kettenbach GmbH & Co. KG | 09/03/2026SE |
| K253052 | Fluoride Varnish (Type A,Type C)LBH · Traditional | Nagy Oral Technology Qinhuangdao Co., Ltd. | 06/11/2026SE |
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | Voco GmbH | 05/01/2026SE |
| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)LBH · Traditional | Sangi Co., Ltd. | 03/18/2026SE |
| K250714 | FluoroDose VarnishLBH · Traditional | Centrix, Inc. | 11/21/2025SE |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3%…LBH · Traditional | Theodent, LLC | 05/27/2025SE |
| K241489 | ReminGelLBH · Traditional | Inter-Med, Inc. | 01/08/2025SE |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional | GreenMark Biomedical, Inc. | 01/02/2025SE |
| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
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 |
| K040858 | Oralief Therapy for Sensitive TeethLBH · Traditional | 09/02/2004SE |
| K041371 | Butler Nucare Prophylaxis Paste with NovaminEJR · Traditional | 08/23/2004SE |
| K033295 | Butler Nucare Root Conditioner with NovaminLBH · Traditional | 10/28/2003SE |
Questions and answers
When was Oravive Tooth Revitalizing Paste cleared by the FDA?
Oravive Tooth Revitalizing Paste (K040473) received a 510(k) decision of Substantially Equivalent on March 10, 2004, 15 days after the submission was received.
What is the product code of K040473?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.