# EEG: Heat Source For Bleaching Teeth

- Device class: 1; regulation: 21 CFR 872.6475; FDA's rule: 510(k) exempt
- FDA decisions: 12
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1979: 1
- 1983: 1
- 1986: 2
- 1989: 1
- 1990: 1
- 2004: 2
- 2005: 1
- 2007: 1
- 2012: 2

## Most-cited predicates
- K042153: South Beach Smile Light Whitening System (2004), cited by 4
- K041392: Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US (2004), cited by 2
- K884937: Beehive-64 or Beehive-32, Digital Eeg Recording (1989), cited by 1
- K052040: Quicksmile (2005), cited by 1

Source page: https://510kreport.com/product-code/EEG
Data by year (CSV): https://510kreport.com/product-code/EEG.csv