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510(k) K250804

ID LIGHT CURE SYSTEM by Id Korea Co., Ltd. — Product Code EBD

K250804 is an FDA 510(k) premarket notification submitted by Id Korea Co., Ltd. for the device "ID LIGHT CURE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 4, 2025. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2025
Date Received
March 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type

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  • K162408 — Nano Varnish, Plaquit, Lightpaint on Surface (April 5, 2018)
  • K163568 — SHOFU RESIN GLAZE (August 16, 2017)
  • K133836 — OPTIGLAZE COLOR (March 6, 2014)
  • K123761 — VITA ENAMIC STAINS (March 1, 2013)
  • K093019 — ENAMELITE ACRYSEAL SPRAY SEALANT (December 22, 2009)
  • K082285 — EASY GLAZE (October 24, 2008)

FDA data resources