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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank; Zirconia Blocks; Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Classification Name: POWDER, PORCELAIN
Product Code: EIH
Device Class: 2
Regulation Number: 872.6660
Medical Specialty: Dental
Registered Establishment Name: ZIRDENT NEW MATERIAL CO.,LTD
Registered Establishment Number: 3021284321
Premarket Submission Number: K212259
Owner/Operator: Zirdent New Material Co.,Ltd
Owner/Operator Number: 10083428
Establishment Operations: Manufacturer
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