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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Bts S.P.A. devices

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
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 127d · 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.