Oralief Otc Toothpaste for Sensitive Teeth

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K080228 ↗

FDA Product Code

LBH

Device Class

Class II

Regulation

21 CFR Part 872.3260

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Oralief Therapy for Sensitive Teeth

  Class II

  FDA 510(k) K040858 Active Cleared 2 Sep 2004

• Butler Nucare Root Conditioner with NovaMin

  Class II

  FDA 510(k) K033295 Active Cleared 28 Oct 2003

• Denshield Treatment for Sensitive Teeth

  Class II

  FDA 510(k) K061359 Active Cleared 18 Oct 2006

• Butler Nucare Prophylaxis Paste with Novamin

  Class I

  FDA 510(k) K041371 Active Cleared 23 Aug 2004

• Periosrp Tooth Root Conditioner with Novamin

  Class II

  FDA 510(k) K071267 Active Cleared 18 May 2007

• Oravive Tooth Revitalizing Paste

  Class II

  FDA 510(k) K040473 Active Cleared 10 Mar 2004

• What is ORALIEF OTC Toothpaste for Sensitive Teeth used for?

  ORALIEF OTC Toothpaste for Sensitive Teeth is designed for daily use by patients to clean teeth and reduce dentin hypersensitivity. It contains NovaMin®, which reacts with saliva or water to form hydroxycarbonate apatite that physically occludes exposed dentin tubules, thereby reducing sensitivity.

• Is ORALIEF OTC Toothpaste for Sensitive Teeth fluoride-free and non-aqueous?

  Yes, ORALIEF OTC Toothpaste for Sensitive Teeth is formulated as a fluoride-free, non-aqueous dentifrice. This means it does not contain fluoride and is not water-based, which allows the NovaMin® active ingredient to remain stable until it contacts an aqueous environment like saliva.

• How is ORALIEF OTC Toothpaste for Sensitive Teeth supplied and regulated?

  ORALIEF OTC Toothpaste for Sensitive Teeth is supplied as a toothpaste for over-the-counter (OTC) use. It is regulated under FDA 510(k) clearance K080228 with product code LBH and device class 2, indicating it was found substantially equivalent to a legally marketed predicate device.