# K021253: Ultrasonic Tips with Diamond Coating

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Endo/Analytic
- Decided: Jul 5, 2002 after 77 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) Sybron Endo/Analytic, Ultrasonic Tips: named in the summary without a submission number

## Indications for use
The intended use of the Ultrasonic Tips with Diamond Coating is for endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal.

Source page: https://510kreport.com/device/K021253
Methodology: https://510kreport.com/methodology