# K990545: Jetsonic 2000

- Pathway: 510(k) (Traditional)
- Applicant: Sds Dental, Inc.
- Decided: Aug 11, 1999 after 170 days
- Product code: KOJ (Airbrush)
- Device class: 2
- Regulation: 21 CFR 872.6080
- 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) Dentsply: named in the summary without a submission number

## Indications for use
This unit combines both ultrasonic scaling and airpolishing functions in one compact unit that answers all prophylaxis needs. The air polishing function is intended to be used to remove stubborn stains, plaque and soft debris. The scaler funtions is intended to be used for cauculus removal. Device applications: Routine oral prophylaxis, routine polishing especiaily in hard to reach fissures and interproximal areas, pnor to enamel etching and bonding techiniques and prior to bonding orthodontic bands and brackets.

Source page: https://510kreport.com/device/K990545
Methodology: https://510kreport.com/methodology