510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K123161Substantially Equivalent

Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite

Smartguard, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123161 is the FDA 510(k) clearance record for SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE, cleared for Smartguard, Inc. on under FDA product code MQC (Mouthguard, Prescription). FDA records list one 510(k) clearance for Smartguard, Inc. As of , FDA records show no recalls naming K123161.

Clearance record

Decision date
Received
(156 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
Smartguard, Inc. 601 Brickell Key Dr., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQC

Trailing 12 months
3 clearances under product code MQC in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260