510(k) Report

FDA applicant

Guangzhou Heygears IMC., Inc.

Guangzhou, CN4 decisions2022–20260 recalls

FDA records 4 decisions for Guangzhou Heygears IMC., Inc. (Guangzhou, CN) from 2022 to 2026: 4 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and MQC (Mouthguard, Prescription). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 79 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Guangzhou Heygears IMC., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 12026 (partial year): 2
2022high 2 (2026) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Guangzhou Heygears IMC., Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing2decisions
  • MQCMouthguard, Prescription1decision
  • EBGCrown And Bridge, Temporary, Resin1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 57 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 79 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc. · 2026
  • K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc. · 2026
  • K253324UltraPrint-Dental Denture UVGuangzhou Heygears IMC., Inc. · 2025
  • K213643UltraPrint-Dental Temp C&B UVGuangzhou Heygears IMC., Inc. · 2022

All 4 as Guangzhou Heygears IMC., Inc. →