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Reva Thermoforming Sheet Material
Ulab Systems, Inc. · Model FG0010 · UDI-DI 00860461001790
10
510(k) clearances
586
Adverse events
2
Recalls
82
Facilities
Description
The uLab Systems Reva Disc is a non-sterile sheet of thermoplastic intended to be used by a dental practitioner to fabricate polymer orthodontic and dental appliances. The sheets of material are heated by the dental practitioner in an office setting and then vacuum-formed over a dental impression of the patient’s teeth. Once formed, the appliance is then trimmed to fit the 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.