K981546 - NTI CLENCHING SUPPRESSION SYSTEM (FDA 510(k) Clearance)

K981546 is an FDA 510(k) clearance for the NTI CLENCHING SUPPRESSION SYSTEM. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on July 15, 1998 after a review of 76 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 Heraeus Kulzer, Inc. devices