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Osstem Implant Co.,Ltd.
Osstem Implant Co.,Ltd. · Model BeauTis White Light · UDI-DI 08800000995755
10
510(k) clearances
85
Adverse events
0
Recalls
118
Facilities
Description
The BeauTis White Light is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis White Light is a medical device that can be used by male and female adults and can be operated by an individual. The BeauTis White Light is classifiled as Class ll and Type BF applied part. The nornal maximum operation condition is 5 min operation, 5 min rest for BeauTis White Light. The degree of protection against harmful ingress of water is IP21
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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.