# ELM: Denture, Plastic, Teeth

- Device class: 2; regulation: 21 CFR 872.3590; FDA's rule: 510(k) exempt
- FDA decisions: 55
- 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)
- 2002: 4
- 2003: 1
- 2004: 1
- 2006: 5
- 2007: 1
- 2009: 1
- 2010: 3
- 2012: 5
- 2013: 2
- 2014: 1

## Most-cited predicates
- K030588: Artegral and Polystar Selection (2003), cited by 4
- K022300: Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi Dent V (2002), cited by 4
- K070591: Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth (2007), cited by 2
- K033628: ARTIC (2004), cited by 2
- K061337: Wiedent Estetic (2006), cited by 2
- K931162: King-Hue, Royal Coral, Super-C Artificial Teeth (1993), cited by 2
- K914476: Vitapan Acrylic Denture Teeth (1992), cited by 1
- K022299: Trilux, Z-Tone, Acry Rock (2002), cited by 1
- K962456: SR Antaris Anterior Teeth/SR Postaris Posterior Teeth (1996), cited by 1
- K844349: SR Vivodent PE Anterior Teeth & SR Orthotyp RE Pos (1984), cited by 1

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