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510(k) K213643

UltraPrint-Dental Temp C&B UV by Guangzhou Heygears IMC., Inc. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2022
Date Received
November 18, 2021
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 Guangzhou Heygears IMC., Inc.

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  • K253324 — UltraPrint-Dental Denture UV (November 20, 2025)

Other clearances for product code EBG

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  • K251271 — TempFIT Temporary Crown and Bridge Resin (June 23, 2025)
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  • 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)