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Panthera Occlusal Appliance - Single
Panthera Dentaire Inc · Model 1 · UDI-DI 07540204000077
1
510(k) clearances
586
Adverse events
2
Recalls
82
Facilities
Description
The Panthera Occlusal Appliance is indicated for protection of teeth and restorations from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.
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.