# K070866: Asc-12 Piezoelectric Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Aseptico, Inc.
- Decided: Apr 11, 2007 after 13 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
Longest line of descent: 2 generations back to K942139 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961158: Suprasson P5 Booster, Satelec (1996) Summary page 1.
- K031421: Ultrasonic Scaler, Models Varios 350 Lux, Varios 350 (NO Light), Varios 550, Varios 150 Lux, Varios 150 (NO Light), Nakanishi, Inc. (2004) Summary page 1.

## Indications for use
The ASC-12 is an ultrasonic scaler that is intended for the following procedures: Scaling: Interdentium treatment Tooth neck and subgingival treatment Treatment of large dental calculi Treatment of coatings and tobacco stains Treatment of periodontal pockets Interproximal treatment Loosening of crowns and posts Endodontics: Pulp Chamber Cleaning Canal filling by ultrasonic gutta-percha condensation

Source page: https://510kreport.com/device/K070866
Methodology: https://510kreport.com/methodology