# K043373: Dolotens Dental TM 1

- Pathway: 510(k) (Abbreviated)
- Applicant: Neuromuscular Technologies, Inc.
- Decided: Sep 2, 2005 after 268 days
- Product code: KZM (Device, Muscle Monitoring)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K842223 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031998: Model J-5 Mvo-Monitor, Myotronics-Noromed, Inc. (2003) Summary page 1.

## Indications for use
The DOLOTENS Dental TM 2 is indicated for the following uses: 1. To treat temporomandibular joint (TMJ) dysfunction and associated pain. 2. To relieve symptoms associated with muscle spasm. 3. To relax muscles and establish a physiologic occlusion 4. To take occlusal registrations 5. To take denture impressions 6. To increase local blood circulation 7. To maintain or increase mandibular range of motion.

Source page: https://510kreport.com/device/K043373
Methodology: https://510kreport.com/methodology