Beaucav Cavity Varnish

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

Full name

Beaucav

510(k) Number

K812550 ↗

FDA Product Code

LBH

Device Class

Class II

Regulation

21 CFR Part 872.3260

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Secure

  Class II

  FDA 510(k) K810715 Active Cleared 21 Apr 1981

• Beaucor

  Class II

  FDA 510(k) K812551 Active Cleared 23 Sep 1981

• Micro Join, Crown & Bridge Adhesive

  Class II

  FDA 510(k) K823935 Active Cleared 7 Feb 1983

• Support

  Class II

  FDA 510(k) K810479 Active Cleared 17 Mar 1981

• Beauseal

  Class II

  FDA 510(k) K812549 Active Cleared 25 Sep 1981

• Cobeau

  Class II

  FDA 510(k) K812548 Active Cleared 25 Sep 1981

See all devices from Sci-Pharm, Inc. →

• What is the Beaucav Cavity Varnish used for?

  The Beaucav Cavity Varnish is designed to create a protective barrier over prepared tooth surfaces during dental procedures. This helps prevent caries (tooth decay) by sealing the cavity and promoting remineralization, which strengthens the tooth structure. It is specifically intended for use in dental offices and clinics as part of restorative or preventive treatments.

• Is the Beaucav Cavity Varnish single-use or reusable?

  The Beaucav Cavity Varnish is supplied as a single-use dental material. This ensures sterility and safety for each application, adhering to standard aseptic techniques required in dental settings. Single-use products like this minimize cross-contamination risks and reduce the need for reprocessing.

• What is the product code for the Beaucav Cavity Varnish?

  The product code for the Beaucav Cavity Varnish variant described is LBH. This code helps identify the specific variant within Sci-Pharm’s lineup of dental materials, ensuring proper ordering and inventory management in dental practices.

• How is the Beaucav Cavity Varnish regulated?

  The Beaucav Cavity Varnish is classified as a Class II medical device under FDA regulation 872.3260 and has received FDA 510(k) clearance (K812550) with a decision labeled as *Substantially Equivalent (SESE)*. This means it meets FDA standards for safety and effectiveness by demonstrating equivalence to a legally marketed predicate device. The clearance was granted in 1981.

• Can the Beaucav Cavity Varnish be used with MRI procedures?

  There is no information provided in the specifications regarding the MRI safety of the Beaucav Cavity Varnish. If MRI compatibility is a concern for a patient, clinicians should verify this with the manufacturer or consult additional safety data before use. Always prioritize patient safety when considering device applications.