Home › Device types › MQC
Mouthguard, Prescription
FDA product code MQC · Class U · Unknown
979
Registered devices
591
Adverse events
2
Recalls
72
510(k) clearances
Devices with this code
E-Guard Blue — Envisiontec GmbHoptimill memosplint — dentona AGDURAGUARD — DENTSPLY SIRONA ORTHODONTICS INC.Erkoflex — Erkodent Erich Kopp GmbHPMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.KeyPrint — Keystone IndustriesEssix ACE® — DENTSPLY SIRONA ORTHODONTICS INC.Square duraforce — DENTSPLY SIRONA ORTHODONTICS INC.Erkodur freeze — Erkodent Erich Kopp GmbHPMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATIONLuxaPrint Ortho Plus NX 385 nm — DMG Digital Enterprises SEM-PM Crystal — Merz Dental GmbHDURAGUARD — DENTSPLY SIRONA ORTHODONTICS INC.Pearson — Keystone IndustriesV-Print splint comfort — VOCO GmbHiFlex by TCS — THERMOPLASTIC COMFORT SYSiNterra™ iNoffice Nightguard — DENTSPLY INTERNATIONAL INC.PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.IDODENTINE — UNION DENTAL SAEssix A+ — DENTSPLY SIRONA ORTHODONTICS INC.DD Bio Splint P HI — Dental Direkt GmbHBioTemps — Prismatik Dentalcraft, IncProform — Keystone IndustriesEssix ACE® — DENTSPLY SIRONA ORTHODONTICS INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-20 | Keystone Industries | Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip |
| 2021-06-25 | Straumann USA LLC | Product label intended for the European community was distributed to the USA market via their US distribution organization |
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