Tubulitec Primer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864052 ↗

FDA Product Code

LBH

Device Class

Class II

Regulation

21 CFR Part 872.3260

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Tubulicid Red Label

  Class II

  FDA 510(k) K864051 Active Cleared 10 Dec 1986

• Tubulicid Blue Label

  Class II

  FDA 510(k) K864050 Active Cleared 5 Dec 1986

• Tubulitec Liner

  Class II

  FDA 510(k) K864053 Active Cleared 5 Dec 1986

• What is the Tubulitec Primer used for in dental procedures?

  The Tubulitec Primer is a cavity varnish designed to seal dentinal tubules in prepared cavities. It creates a protective layer that reduces microleakage and improves the bonding between restorative materials (like fillings) and the natural tooth structure, helping to ensure long-term retention of the restoration.

• Is the Tubulitec Primer sterile, and how is it supplied?

  The Tubulitec Primer is non-sterile and is supplied in individual, single-use applicator units. This design ensures each unit is used only once, maintaining hygiene and preventing cross-contamination between patients.

• What storage conditions are required for the Tubulitec Primer?

  The device must be stored at controlled room temperature. Proper storage ensures stability and effectiveness, as extreme temperatures could compromise its performance as a cavity varnish.

• How was the Tubulitec Primer approved by the FDA, and what regulatory pathway was used?

  The Tubulitec Primer holds an FDA 510(k) clearance (K864052) under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. The classification is Class II, and it was reviewed by the Dental Devices (DE) Advisory Committee.

• Can the Tubulitec Primer be reused, or is it intended for single-use only?

  The Tubulitec Primer is explicitly designed for single-use only, as it comes in individual applicator units. Reusing it would violate manufacturer guidelines and could compromise patient safety by introducing contamination or reducing efficacy.