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Night Guard
3D DIAGNOSTIX, INC. · Model Printed Night Guard · UDI-DI 00850073333013
MQC
Prescription
1
510(k) clearances
586
Adverse events
2
Recalls
82
Facilities
Description
Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients-specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile. Reusable Device /Single consumer, Patient
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 lock bag along with |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.