# K971732: Dental Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Pauline M. Nicholls
- Decided: Jan 11, 2000 after 977 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) highspeed handpiece: named in the summary without a submission number

## Indications for use
THIS DENTAL HANDPIECE, AS ALL OTHER DENTAL HANDPIECES, WILL BE USED INTRA AND EXTRA ORALLY TO CUT, SHAPE, GRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.

Source page: https://510kreport.com/device/K971732
Methodology: https://510kreport.com/methodology