FDA product code MQC: Mouthguard, Prescription
MQC is the FDA product code for mouthguard, prescription. It is a Unclassified device, reviewed by the Dental panel. FDA has cleared 71 510(k) submissions under MQC, 24 in the last five years, from 64 different applicants. The average 510(k) review took 190 days (median 184); 171 days on average over the last three years. FDA has posted 2 recalls for MQC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mouthguard, Prescription |
| Device class | Unclassified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for MQC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 228 |
| 2019 | 5 | 253 |
| 2020 | 4 | 194 |
| 2021 | 7 | 150 |
| 2022 | 5 | 146 |
| 2023 | 6 | 208 |
| 2024 | 8 | 234 |
| 2025 | 4 | 184 |
| 2026 | 1 | 94 |
Compare with all 510(k) review times · Search every MQC clearance
Top MQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Whip Mix Corporation | 2 | 2025-03-18 |
| Formlabs Ohio, Inc. | 2 | 2024-02-16 |
| Prismatik Dentalcraft, Inc. | 2 | 2023-02-17 |
| Envisiontec GmbH | 2 | 2022-06-10 |
| Pro3Dure Medical GmbH | 2 | 2022-04-08 |
59 more applicants have MQC clearances. See the full list in Caduvo.
Most recent MQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253798 | Guangzhou Heygears IMC., Inc. | UltraPrint-Dental Hard Splint UV | 2026-03-02 | 94 |
| K250743 | Remvia | Remvia NightGuard | 2025-12-05 | 269 |
| K251252 | Shandong Huge Dental Material Corporation | NOBILCAM IMPAK Disc | 2025-08-01 | 100 |
| K241729 | Whip Mix Corporation | Hard Splint & Thermo-Adaptive Splint | 2025-03-18 | 277 |
| K243516 | Grindguard, Inc. | Remi Custom Night Guard | 2025-02-10 | 89 |
Recalls for MQC devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2023-11-20.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code MQC?
MQC is the FDA product code for mouthguard, prescription. It is a Unclassified device, reviewed by the Dental panel.
What device class is MQC?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQC?
Across 71 cleared submissions the average was 190 days from receipt to decision (median 184).
Which companies have the most MQC clearances?
Whip Mix Corporation (2); Formlabs Ohio, Inc. (2); Prismatik Dentalcraft, Inc. (2); Envisiontec GmbH (2); Pro3Dure Medical GmbH (2).
Have MQC devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-11-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MQC
- Run a recall and safety report across every MQC manufacturer
- Watch product code MQC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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