# K012720: Tulsa Contra Angles

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Nov 8, 2001 after 85 days
- Product code: EFB (Handpiece, Air-Powered, 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 K944719 (1995). 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)
- K944719: W&H 100 Series Low Speed, A-Dec, Inc. (1995) Summary page 1.

## Indications for use
These contra angles are designed to be used with dental motors for: Model TUL-1: For endodontic procedures, removing carious material, reducing hard tooth structure, cavity preparations, finishing tooth preparations and restorations, and polishing teeth Models TUL-8M and TUL16-MT: Mechanical root canal preparation with rotating files

Source page: https://510kreport.com/device/K012720
Methodology: https://510kreport.com/methodology