# K063302: Sdif Dental Chair with Operative Unit and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Dental Instrument Factory
- Decided: Nov 15, 2006 after 14 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962071 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052470: F1 Series Dental Chairs with Operative Unit, Shanghai Fimet Medical Instrument Co., Ltd. (2005) Summary page 1.

## Indications for use
SDIF Dental chairs with operative unit is indicated for use to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is indicated for use in the dental clinic/office environment used by trained dentists and/or dental technicians and assistants

Source page: https://510kreport.com/device/K063302
Methodology: https://510kreport.com/methodology