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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: DaVinci Remineralizing and Desensitizing Gel (TM 18); DaVinci Shield and Shimmer Tooth Sealant; DaVinci Teeth Whitening Gel (CP 20%) (CP 35%); DaVinci Teeth Whitening Gel (HP 1%) (HP 6%) (HP 12%) (HP 17%); DaVinci Teeth Whitening Pen (HP 12%)
Classification Name: ERASER, DENTAL STAIN
Product Code: MAU
Device Class: 1
Regulation Number: 872.6855
Medical Specialty: Dental
Registered Establishment Name: DAVINCI TEETH WHITENING
Registered Establishment Number: 3008650098
Owner/Operator: DaVinci Teeth Whitening
Owner/Operator Number: 10033560
Establishment Operations: Contract Manufacturer; Manufacturer