Cleared Traditional

K113677 - GRINDCARE MEASURE

K113677 is an FDA 510(k) clearance for GRINDCARE MEASURE, manufactured by Medotech A/S. The device is a Class 2 Dental device with product code KZM cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K113677 · Medotech A/S · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
113d
Days
Class 2
Risk

K113677 is an FDA 510(k) clearance for the GRINDCARE MEASURE. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Medotech A/S (Westminster, US). The FDA issued a Cleared decision on April 5, 2012 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.1375 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K113677

510(k) Number K113677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2011
Decision Date April 05, 2012
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 128d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZM Device Classification - Class 2, Special Controls

Product Code KZM Device, Muscle Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KZM Device, Muscle Monitoring

All 15
Devices cleared under the same product code (KZM) and FDA review panel - the closest regulatory comparables to K113677.
TEETHAN 2.0
K161716 · Bts S.P.A. · Dec 2016
M-SCAN
K130158 · Bio-Research Associates, Inc. · Jul 2013
BIOEMG III
K082927 · Bio-Research Associates, Inc. · Feb 2009
DOLOTENS DENTAL TM 1
K043373 · Neuromuscular Technologies, Inc. · Sep 2005
BITESTRIP
K030869 · S.L.P. , Ltd. · May 2004
BIOEMG II AND BIOJVA
K003176 · Bio-Research Associates, Inc. · Jan 2001
K113677 · GRINDCARE MEASURE
Download PDF FDA Summary Medotech A/S