Cleared Traditional

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

K981546 · Heraeus Kulzer, Inc. · Dental device
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Jul 1998
Decision
76d
Days
-
Risk

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

Submission Details

510(k) Number K981546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1998
Decision Date July 15, 1998
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -