Seal & Protect Protective Sealant

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

510(k) Number

K021805 ↗

FDA Product Code

LBH

Device Class

Class II

Regulation

21 CFR Part 872.3260

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Dentsply Intl. →

• What is the primary clinical purpose of Seal & Protect Protective Sealant?

  This device is a cavity varnish intended for application to exposed root surfaces. It functions by sealing exposed dentinal tubules and reinforcing the dentin to increase surface hardness, which helps address hypersensitivity and assists in the prevention of class V lesions.

• How does this sealant protect the tooth surface?

  The sealant works by mechanically reinforcing the dentin structure. By sealing the exposed dentinal tubules, it creates a protective barrier that increases the surface hardness of the root dentin and helps it resist abrasion caused by toothbrushing.

• What is the regulatory status of this device?

  Seal & Protect Protective Sealant is authorized under FDA 510K, identified by the K-number K021805. It is categorized within the dental specialty under regulation number 872.3260.