510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MQCUnclassified

Mouthguard, Prescription

Unknown
FDA source (opens on fda.gov)

MQC is the FDA product code for Mouthguard, Prescription. As of , FDA records hold 71 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
MQC
Device name
Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
71
Ingested recalls
2

Clearances, product code MQC

By decision year
71 clearances under product code MQC with a decision year between 1996 and 2026, 2024 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code MQC by decision year
YearClearances
19961
19982
20021
20034
20041
20062
20074
20092
20101
20114
20122
20131
20141
20153
20172
20195
20204
20217
20225
20236
20248
20254
20261

Applicants with the most clearances

Product code MQC
Applicants holding the most 510(k) clearances under product code MQC
ApplicantClearances
PRO3DURE Medical GmbH3
Dental Concepts, LLC2
Envisiontec GmbH2
Formlabs Ohio, Inc.2
Power Products, Inc.-Splintek2
Prismatik Dentalcraft, Inc.2
Whip-Mix Corp.2
12th Man Technologies, Inc.1
3D Diagnostix Inc1
3Shape A/S1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 78 companies shown, in name order