# K881253: Rotory Scaler Swivel Improvement Feature, Titan SW

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez Group
- Decided: Apr 21, 1988 after 29 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 30, 2024 · Class II · Z-2177-2024: Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
- May 30, 2024 · Class II · Z-2178-2024: Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury

Source page: https://510kreport.com/device/K881253
Methodology: https://510kreport.com/methodology