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510(k) K043373

DOLOTENS DENTAL TM 1 by Neuromuscular Technologies, Inc. — Product Code KZM

K043373 is an FDA 510(k) premarket notification submitted by Neuromuscular Technologies, Inc. for the device "DOLOTENS DENTAL TM 1". The FDA issued a decision of Substantially Equivalent on September 2, 2005. The device falls under product code KZM (Device, Muscle Monitoring), a Class II device regulated under 21 CFR 890.1375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2005
Date Received
December 8, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Muscle Monitoring
Device Class
Class II
Regulation Number
890.1375
Review Panel
DE
Submission Type

Other clearances for product code KZM

  • K161716 — TEETHAN 2.0 (December 21, 2016)
  • K130158 — M-SCAN (July 25, 2013)
  • K113677 — GRINDCARE MEASURE (April 5, 2012)
  • K082927 — BIOEMG III (February 6, 2009)
  • K030869 — BITESTRIP (May 14, 2004)
  • K003176 — BIOEMG II AND BIOJVA (January 4, 2001)
  • K003287 — MODEL K7 EVALUATION DEVICE (November 6, 2000)
  • K992694 — MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I (September 10, 1999)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)
  • K944134 — K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 (December 9, 1994)

FDA data resources