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510(k) K222489

Harvest Printable Resin by Harvest Dental Products, LLC — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2023
Date Received
August 17, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
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)
  • K180578 — Harvest Dental Polymer Blocks (December 12, 2018)
  • K132937 — HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) (May 21, 2014)

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