FDA 510(k), K921820, RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION

FDA 510(k), K921820, RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION

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510(K) Number: K921820
Device Name: RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION
Manufacturer: COSMEDENT, INC.
Device Classification Name: material, tooth shade, resin
Regulation Number: 872.3690
Classification Product Code: EBF
Date Received: 04/14/1992
Decision Date: 06/16/1992
Regulation Medical Specialty: Dental
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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