# K162397: Titan 3 Low Speed Angle Attachments

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez, Inc.
- Decided: Jan 19, 2017 after 146 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983574 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983574: Stardental Titan 3 Lubefree Motor Attachments, Dentalez Group (1999) Summary page 4.

## Indications for use
Titan 3 Low Speed Angle Attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings, as well as disking, cavity and crown preps, polishing, post and pin drilling and pin setting.

Source page: https://510kreport.com/device/K162397
Methodology: https://510kreport.com/methodology