# K970134: Thermaprep Plus Oven

- Pathway: 510(k) (Traditional)
- Applicant: Tulsa Dental Products, Ltd.
- Decided: Mar 21, 1997 after 65 days
- Product code: EKM (Gutta-Percha)
- Device class: 1
- Regulation: 21 CFR 872.3850
- 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 K910224 (1991). 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)
- K910224: Thermaprep, Tulsa Dental Products, Ltd. (1991) Summary page 1.

## Indications for use
The THERMAPREP® PLUS OVEN is specially developed for heating ThermaFil® endodontic obturators. Do not use the oven for any other purpose.

Source page: https://510kreport.com/device/K970134
Methodology: https://510kreport.com/methodology