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510(k) K132937

HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) by Harvest Dental Products, LLC — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2014
Date Received
September 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type

Other clearances by Harvest Dental Products, LLC

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  • K222961 — Harvest Conceal ZR Block Out (June 2, 2023)
  • K222489 — Harvest Printable Resin (May 12, 2023)
  • K180578 — Harvest Dental Polymer Blocks (December 12, 2018)

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  • K243370 — DentaTOOTH (May 5, 2025)
  • K243621 — Evoblock, Perléon (April 22, 2025)
  • K243951 — TEMP MASTER, PMMA-based dental resin (February 21, 2025)
  • K231859 — PrimmaArt (November 26, 2024)
  • K242559 — Digital Temp (November 26, 2024)
  • K240538 — Premium Teeth Resin (July 19, 2024)
  • K241226 — Fixtemp® C&B 4:1 (May 31, 2024)