Home / 510(k) Clearances / K223477

510(k) K223477

PMMA Blocks for Dental Use by Aidite (Qinhuangdao) Technology Co., Ltd. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2023
Date Received
November 18, 2022
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 Aidite (Qinhuangdao) Technology Co., Ltd.

  • K251415 — Additively Manufactured Aligner Resin (August 27, 2025)
  • K250534 — Biomic Color Opaque (May 20, 2025)
  • 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)
  • K242884 — Additively Manufactured Denture Resin (November 22, 2024)
  • 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)
  • K222626 — Dental Zirconia Ceramic (December 6, 2022)

Other clearances for product code EBG

  • K253380 — “FLNT Base” and “FLNT Temp” (March 2, 2026)
  • K251271 — TempFIT Temporary Crown and Bridge Resin (June 23, 2025)
  • 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)
  • K233868 — dima Print Teeth & Temp (May 23, 2024)