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Ultra-Lite
ROLENCE ENTERPRISE INC. · Model 5 Turbo · UDI-DI 04713909450505
1
510(k) clearances
171
Adverse events
4
Recalls
103
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-20 | Envisiontec US Llc | The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. |
| 2018-04-04 | Handpiece Headquarters | Tip of the curing light was too hot causing a heat sensation in the patients. |
| 2014-04-14 | Ivoclar Vivadent, Inc. | A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes. |
| 2012-04-23 | O'Ryan Industries Inc | Disposa-Shield Disposable Curing Shield is recalled due to lacking 510K, PMA or IDE, and inadequate quality system. |
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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.