# DZM: Needle, Dental

- Device class: 1; regulation: 21 CFR 872.4730; FDA's rule: 510(k) exempt
- FDA decisions: 16
- 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)
- 1982: 1
- 1984: 1
- 1985: 1
- 1986: 1
- 1987: 2
- 1989: 1
- 1990: 1
- 1991: 3
- 1992: 2
- 1999: 1

## Most-cited predicates
- K913573: Safety Plus Dental Injection Needle (1991), cited by 1
- K910446: Stabident Local Anesthesia System (1991), cited by 1

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