# K221814: OK Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Jaintek Co.,Ltd
- Decided: Jul 15, 2022 after 23 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
Longest line of descent: 1 generation back to K082827 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082827: A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece Attachment, A-Dec, Inc. (2009) Summary page 4.

## Indications for use
A dental contra-angle handpiece that attaching a vertical reciprocating dental strips intended to be used in interproximal reduction of teeth; And it is part of orthodontic treatment of finishing interdental and subgingival area, finishing cavity edges, removing the dentin of teeth adjacent, removing subgingival plague and tripping. The device incorporates a small micro motor normally driven by compressed air; This is a reusable device.

Source page: https://510kreport.com/device/K221814
Methodology: https://510kreport.com/methodology