Cleared Traditional

K161716 - TEETHAN 2.0

K161716 is an FDA 510(k) clearance for TEETHAN 2.0, manufactured by Bts S.P.A.. The device is a Class 2 Dental device with product code KZM cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K161716 · Bts S.P.A. · Dental device
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Dec 2016
Decision
183d
Days
Class 2
Risk

K161716 is an FDA 510(k) clearance for the TEETHAN 2.0. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Bts S.P.A. (Padova, IT). The FDA issued a Cleared decision on December 21, 2016 after a review of 183 days - an extended review cycle.

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 - K161716

510(k) Number K161716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2016
Decision Date December 21, 2016
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 128d · This submission: 183d
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 Consultant

Namsa
JULIE SHERMAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K161716.
M-SCAN
K130158 · Bio-Research Associates, Inc. · Jul 2013
GRINDCARE MEASURE
K113677 · Medotech A/S · Apr 2012
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
K161716 · TEETHAN 2.0
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