# K133078: K-Etchant Syringe; Needle Tip (E)

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Dec 20, 2013 after 84 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931812 (1993). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062409: K-Etchant Gel, Kuraray Medical, Inc. (2006) Summary page 1.
- K101485: All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with Bac; Dark- Etch, Dark Etch (Blue- E, Bisco, Inc. (2010) Summary page 1.
- K032455: Panavia F 2.0, Kuraray Medical, Inc. (2003) Summary page 1.
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001) Summary page 1.
- K031968: Cerabien ZR, Noritake Co., Inc. (2003) Summary page 1.

## Indications for use
1. Etching of enamel and dentin 2. Cleaning of dental restorative materials

Source page: https://510kreport.com/device/K133078
Methodology: https://510kreport.com/methodology