510(k) · Cleared

Cleared

Dolotens Dental TM 1

K043373510(k) AbbreviatedCleared Sep 2, 2005268-day reviewClass II21 CFR 890.1375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neuromuscular Technologies, Inc. · KZM Device, Muscle Monitoring

Cleared on Sep 2, 2005 as substantially equivalent to K031998 (Myotronics-Noromed, Inc., 2003) after a 268-day review. Its family tree reaches back 2 generations to 1984.

Decided: Sep 2, 2005
Review: 268 days
Class: Class II
Product code: KZM
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K842223 (1984). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK842223 J4 Myo-MonitorMyo-Tronics Research, Inc. · 1984
1 generation backK031998 Model J-5 Mvo-MonitorMyotronics-Noromed, Inc. · 2003
This deviceK043373 Dolotens Dental TM 1Neuromuscular Technologies, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K842223	J4 Myo-Monitor	Myo-Tronics Research, Inc.	1984	—
−1	K031998	Model J-5 Mvo-Monitor	Myotronics-Noromed, Inc.	2003	—
0 (this device)	K043373	Dolotens Dental TM 1	Neuromuscular Technologies, Inc.	2005	—

FIG. 1 — Lineage of K043373, 1984–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KZM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K031998	Model J-5 Mvo-Monitor Summary page 1 …oring Device Product Code: KZM Regulation Number: 890.1375 Substantial Equivalence: The DOLOTENS DENTAL TM 2 is substantially equivalent to the MODEL J-5 MVO-MONITOR (K031998), manufactured by MYOTRONICS-NOROMED, INC. Indications for Use: The DOLOTENS Dental TM 2 is indicated for the following uses: 1.…	Myotronics-Noromed, Inc.	2003	—

Also cleared against K031998: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K031998.

How does its category compare?

All KZM devices

KZM Device, Muscle Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZM

1in 2016

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZM

Too few KZM 510(k)s in any year since 2007 to give a median.

Recalls per year · KZM

No recall names KZM since 2007.

Adverse event reports per year · KZM

No MAUDE report names KZM since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K043373 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043373: Dolotens Dental TM 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043373

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026