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Mouthguard, Prescription
FDA product code MQC · Class U · Unknown
943
Registered devices
584
Adverse events
2
Recalls
71
510(k) clearances
Devices with this code
ESSIX C+® — DENTSPLY SIRONA ORTHODONTICS INC.DURAGUARD — DENTSPLY SIRONA ORTHODONTICS INC.Essix A+ — DENTSPLY SIRONA ORTHODONTICS INC.IDODENTINE — UNION DENTAL SAErkoflex — Erkodent Erich Kopp GmbHErkodur-A1 — Erkodent Erich Kopp GmbHPearson — Keystone IndustriesEssix A+ — DENTSPLY SIRONA ORTHODONTICS INC.Essix + — DENTSPLY SIRONA ORTHODONTICS INC.Erkoflex — Erkodent Erich Kopp GmbHEssix ACE® — DENTSPLY SIRONA ORTHODONTICS INC.iFlex by TCS — THERMOPLASTIC COMFORT SYSProform — Keystone IndustriesIdeal Comfort — DENTSPLY SIRONA ORTHODONTICS INC.iFlex by TCS — THERMOPLASTIC COMFORT SYSPRO3DURE THERMEO Liquid — pro3dure medical GmbHEssix ACE — DENTSPLY SIRONA ORTHODONTICS INC.PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.Primosplint — PRIMOTEC LLCComfort Splint — Prismatik Dentalcraft, IncTrack A — Forestadent Bernhard Förster GmbHPMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.Erkoflex — Erkodent Erich Kopp GmbHPRO3DURE THERMEO Blank — pro3dure medical GmbH
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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