Dolotens Dental 1
by Neuromuscular Technologies, Inc.
510(k) K043373
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043373 | Date2 Sep 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Dolotens Dental Tm 1
- 510(k) Number
- FDA Product Code
- KZM
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.1375
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Dolotens Dental 1 is a Muscle Monitoring device, classified under product code KZM for dental applications. It is designed to assess neuromuscular function, particularly in the context of dental procedures requiring precise control of muscle activity, such as local anesthesia administration or patient relaxation monitoring. This device aids clinicians in evaluating muscle response to electrical stimulation, ensuring optimal patient outcomes during dental treatments.
The Dolotens Dental 1 is supplied as a reusable medical device and is intended for use in clinical settings where neuromuscular monitoring is required. It operates under FDA clearance (K043373) through the Abbreviated 510(k) pathway, classified as a Class II device. No specific sterility or single-use requirements are noted in the regulatory data, though standard infection control practices should be followed. The device is regulated under FDA regulation number 890.1375 and is associated with the Physical Medicine specialty.
Questions
AI-generated answers, 1 Oct 2026
What is the Dolotens Dental 1 used for in dental procedures?
The Dolotens Dental 1 is designed to assess neuromuscular function during dental treatments. It helps clinicians monitor muscle activity in response to electrical stimulation, ensuring precise control of local anesthesia administration and patient relaxation. This is particularly useful for procedures requiring careful muscle management, such as sedation or nerve block applications.
Is the Dolotens Dental 1 a single-use or reusable device?
The Dolotens Dental 1 is a reusable medical device. While no specific sterility requirements are explicitly stated beyond standard infection control practices, its classification as reusable aligns with clinical settings where devices are cleaned and disinfected between uses. Always follow manufacturer guidelines for reprocessing to maintain safety and functionality.
What regulatory pathway does the Dolotens Dental 1 follow?
The Dolotens Dental 1 received FDA clearance through the Abbreviated 510(k) pathway, classified as a Class II device under product code KZM for dental applications. This clearance indicates it is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in neuromuscular monitoring for dental use.
Does the Dolotens Dental 1 require special storage conditions?
The Dolotens Dental 1 does not have documented special storage requirements beyond standard conditions for reusable medical devices. Since it is reusable, it should be stored in a clean, dry environment when not in use, following manufacturer instructions for maintenance and reprocessing. Proper storage helps preserve functionality and ensures readiness for clinical use.
What specialty does the Dolotens Dental 1 fall under in medical regulations?
The Dolotens Dental 1 is regulated under the Physical Medicine specialty, as indicated in its FDA submission. This classification reflects its role in monitoring neuromuscular function, which is critical for procedures requiring precise muscle control, such as those in dental anesthesia or sedation. The device is governed by FDA regulation number 890.1375.