FDA 510(k) K190043, Halley resin, by Dentsply Sirona
FDA 510(k) K190043, Halley resin, by Dentsply Sirona
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
510(k) Number: K190043
Device Name: Halley resin
Applicant: Dentsply Sirona
Regulation Number: 872.376
Classification Product Code: EBI
Date Received: 2019-01-09
Decision Date: 2019-04-24
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
510k Review Panel: Dental
Total number of pages: 664
Fully redacted pages: 405
Content pages: 259
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