Enamelite Enamel Coating

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

510(k) Number

K770109 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Precise(R) Beta Quartz Glass-Ceramic Insert

  Class II

  FDA 510(k) K912256 Active Cleared 24 Jul 1991

• Lee Endofill, Root Canal Filling Resin

  Class II

  FDA 510(k) K810923 Active Cleared 21 Apr 1981

• Ultraviolet Rad-Emitting Lamp

  Class II

  FDA 510(k) K771077 Active Cleared 24 Jun 1977

• Restobond 3/Dentin-Enamel Bonding Agent

  Class II

  FDA 510(k) K894315 Active Cleared 31 Oct 1989

• Cleanse N Bond I

  Class II

  FDA 510(k) K844133 Active Cleared 4 Jan 1985

• Restodent Vl

  Class II

  FDA 510(k) K843363 Active Cleared 25 Oct 1984

See all devices from Lee Pharmaceuticals →

• What types of dental procedures is the Enamelite Enamel Coating intended to support, and how does it work?

  The Enamelite Enamel Coating is designed for protective or restorative enamel applications in dentistry, functioning as a ceramic-based spray coating to strengthen or modify tooth surfaces. It aids in both preventive (e.g., protecting enamel from decay) and restorative (e.g., reinforcing weakened teeth) dental procedures by forming a durable layer over the tooth structure.

• How is the Enamelite Enamel Coating supplied, and what form does it take?

  The Enamelite Enamel Coating is supplied as a spray coating, meaning it is applied directly to teeth in a liquid or aerosolized form that adheres and hardens. This format allows for precise application during dental procedures, ensuring even coverage on tooth surfaces.

• Is the Enamelite Enamel Coating intended for single-use or reusable applications, and what are its storage requirements?

  The available data does not specify whether the Enamelite Enamel Coating is single-use or reusable, nor does it provide explicit sterility requirements or storage instructions. Clinicians should follow manufacturer guidelines (from Lee Pharmaceuticals) for proper handling, storage, and disposal to ensure safety and efficacy.

• What regulatory pathway was used for FDA clearance of the Enamelite Enamel Coating, and when was it approved?

  The Enamelite Enamel Coating was cleared under the FDA’s Traditional 510(k) pathway with a Substantially Equivalent (SESE) decision, dated January 24, 1977, under the Dental (DE) Advisory Committee. This classification means it was deemed comparable to a legally marketed device at the time of submission.