FDA 510(k), K121735, FIBER DISK AND BLOCK PERMANENT, TRINIA

FDA 510(k), K121735, FIBER DISK AND BLOCK PERMANENT, TRINIA

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510(K) Number: K121735
Device Name: FIBER DISK AND BLOCK PERMANENT, TRINIA
Manufacturer: BIOLOREN SRL
Device Classification Name: material, tooth shade, resin
Regulation Number: 872.3690
Classification Product Code: EBF
Date Received: 06/13/2012
Decision Date: 02/21/2013
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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