Whitening

FDA recognizes ISO 28399, Third edition 2021-03, Dentistry — External tooth bleaching products. The recognition entry is 12/23/2024, FR recognition 4-331. The scope covers in-office professional use and consumer home use. Maximum concentration is subject to each country's regulatory body. The recognized standard does not cover lights used with bleaching products, and it does not specify biological safety. Record, retrieved 2026-10-04: recognized consensus standard.

A separate record classifies a heat source for bleaching teeth, product code EEG, regulation 872.6475, device class 1. It is listed as 510(k) exempt, with a caveat to confirm exempt status in 21 CFR. That classification is the heat source, not a gel. Record: product classification.

Education, not a dental practice. Florida Smile Works does not examine, diagnose, or treat.