# EFA: Handpiece, Belt And/Or Gear Driven, Dental

- Device class: 1; regulation: 21 CFR 872.4200; FDA's rule: 510(k) required
- FDA decisions: 25
- Recalls: 2 (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)
- 2000: 1
- 2001: 1
- 2004: 1
- 2006: 2
- 2007: 1
- 2009: 4
- 2010: 2
- 2015: 1
- 2017: 1
- 2020: 1

## Most-cited predicates
- K960719: Star Dental 430 Series High Speed Handpiece (1996), cited by 6
- K040674: Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles (2004), cited by 5
- K092412: Strong Implant Handpieces (2009), cited by 3
- K090676: Montblanc Implantology and Omnipratique Contra-Angles (2009), cited by 2
- K061701: High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H) (2006), cited by 2
- K070084: Montblanc Implantology Contra Angle Control (2007), cited by 1
- K192809: Dental Handpiece (2020), cited by 1
- K163239: SMARTmatic (2017), cited by 1
- K971603: Sterile Sureflex Files and Instruments (1997), cited by 1
- K013185: TCM Endo Iii (2001), cited by 1

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