# K964596: Proselect 3 Peridontal Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Professional Dental Mfg., Inc.
- Decided: Apr 22, 1997 after 155 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- 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) Cavitron® Ultrasonic 3000 Scaler: named in the summary without a submission number
- (no number) Cavitron® Ultrasonic 1010 Scaler: named in the summary without a submission number
- (no number) Cavitron® Ultrasonic 660 Scaler: named in the summary without a submission number
- (no number) Alfa-Sonic Hygienic Scaler Model 300: named in the summary without a submission number
- (no number) Air Flow II Scaler: named in the summary without a submission number

## Indications for use
ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Source page: https://510kreport.com/device/K964596
Methodology: https://510kreport.com/methodology