510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K981546Substantially Equivalent

Nti Clenching Suppression System

Kulzer GmbH, South Bend IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981546 is the FDA 510(k) clearance record for NTI CLENCHING SUPPRESSION SYSTEM, cleared for Heraeus Kulzer, Inc. on under FDA product code MQC (Mouthguard, Prescription). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K981546.

Clearance record

Decision date
Received
(76 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
Heraeus Kulzer, Inc. 4315 S Lafayette Blvd., South Bend IN
510(k) summary
Statement
Third party review
No

Clearances, product code MQC

Trailing 12 months
3 clearances under product code MQC in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQC, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260