# K100647: A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM

- Pathway: 510(k) (Traditional)
- Applicant: A-Dec, Inc.
- Decided: Jul 9, 2010 after 123 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment is intended for use in dental treatment procedures. The automatically operated sonic device can be used, in conjunction with the appropriate tips, for the removal of supra and subgingival calculus, and teeth cleaning procedures.

Source page: https://510kreport.com/device/K100647
Methodology: https://510kreport.com/methodology