Cleared Traditional

NTI TENSION SUPPRESSION SYSTEM (K010876) - FDA 510(k) Clearance

K010876 · Nti-Tss, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
89d
Days
-
Risk

K010876 is an FDA 510(k) clearance for the NTI TENSION SUPPRESSION SYSTEM. Classified as Mouthguard, Migraine/tension Headache (product code OCO).

Submitted by Nti-Tss, Inc. (Mishawaka, US). The FDA issued a Cleared decision on June 20, 2001 after a review of 89 days - a notably fast clearance cycle.

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

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nti-Tss, Inc. devices

Submission Details

510(k) Number K010876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2001
Decision Date June 20, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OCO Mouthguard, Migraine/tension Headache
Device Class -
Definition A Device To Be Used In The Prophylactic Treatment Of Medically Diagnosed Migraine Pain As Well As Migraine Associated Tension-type Headaches, By Reducing Their Signs And Symptoms Through Reduction Of Trigeminally Innervated Muscular Activity, And; For The Prevention Of Bruxism And Tmj Syndrome Through Reduction Of Trigeminally Innervated Muscular Activity.