# K960889: Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod. 300116/Spreader Mod. 300117 Tips

- Pathway: 510(k) (Traditional)
- Applicant: San Diego Swiss Machining, Inc.
- Decided: May 10, 1996 after 67 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.
6 later devices descend from it; 5 cite it directly.
0 of 7 devices 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) Piezon Master 400 Scalers Tips: named in the summary without a submission number
- (no number) Cavitron Ultrasonic Tips Models J-3 and S-3: named in the summary without a submission number
- (no number) Piezo-Electric D Files: named in the summary without a submission number
- (no number) Ultrasonic Neosonics-D: named in the summary without a submission number
- (no number) Endosonic files: named in the summary without a submission number

## Most influential descendants
- K132609: Eds Ultrasonic Tips (2014), 1 descendant of its own
- K230641: Ultrasonic Scaler Tips (2023), 0 descendants of its own
- K182145: tün® ultrasonic tips product family (2019), 0 descendants of its own
- K122501: Aei DR. Terauchi Ultrasonic Tips (2013), 0 descendants of its own
- K053578: Scorpion Ultrasonic Scaling Inserts (2006), 0 descendants of its own

## Indications for use
The San Diego Swiss Machining Sapphire Plus® Tips are utilized in reconstructive dental procedures (crown preparation), periodontic preparative procedures, tissue scaling, plaque/bone removal, endodontic retreatment and root preparation. The devices are used during dertal cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodcntic applications to prepare the tooth and/or root of the tooth for repair.

Source page: https://510kreport.com/device/K960889
Methodology: https://510kreport.com/methodology