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510(k) K242884

Additively Manufactured Denture Resin by Aidite (Qinhuangdao) Technology Co., Ltd. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2024
Date Received
September 23, 2024
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 Aidite (Qinhuangdao) Technology Co., Ltd.

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  • K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin (April 30, 2025)
  • K250811 — Dental Zirconia Ceramic (April 11, 2025)
  • K250025 — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) (March 14, 2025)
  • K241715 — Dental Glass Ceramics Blocks (HT,LT,ST) (July 12, 2024)
  • K230115 — Denture Base Resin (March 17, 2023)
  • K223742 — Dental Ceramic Blocks (March 8, 2023)
  • K223477 — PMMA Blocks for Dental Use (February 16, 2023)
  • K222626 — Dental Zirconia Ceramic (December 6, 2022)

Other clearances for product code EBI

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  • K253324 — UltraPrint-Dental Denture UV (November 20, 2025)
  • K252430 — Freeprint® denture flex (October 30, 2025)
  • K252035 — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p (September 17, 2025)
  • K250302 — Flexible Partial Resin (June 25, 2025)
  • K242897 — Partial Flex (June 3, 2025)
  • K250489 — FP3D (May 20, 2025)
  • K250617 — Apex Flex (April 29, 2025)
  • K243356 — Asiga DentaBASE (April 11, 2025)