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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Lucitone Digital Print for Primeprint
Classification Name: RESIN, DENTURE, RELINING, REPAIRING, REBASING
Product Code: EBI
Device Class: 2
Regulation Number: 872.3760
Medical Specialty: Dental
Registered Establishment Name: DENTSPLY LLC
Registered Establishment Number: 2515379
Owner/Operator: DENTSPLY SIRONA INC
Owner/Operator Number: 2511302
Establishment Operations: Contract Manufacturer
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