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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: MATERIAL, TOOTH SHADE, RESIN
Product Code: EBF
Device Class: 2
Regulation Number: 872.3690
Medical Specialty: Dental
Registered Establishment Name: ZIRCON PLUS LIMITED
Registered Establishment Number: 3026400121
Premarket Submission Number: K120453
Owner/Operator: ZIRCON PLUS LIMITED
Owner/Operator Number: 10087265
Establishment Operations: Foreign Exporter
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