Home / 510(k) Clearances / K051571

510(k) K051571

SKYLIGHT LED CURING LIGHT by Dmetec.Co., Ltd. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2005
Date Received
June 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type

Other clearances by Dmetec.Co., Ltd.

  • K170104 — COMPACT S, COMPACT S (LED) (December 27, 2017)
  • K121620 — ULTRASONIC SURGERY (December 11, 2012)
  • K113152 — ULTRASONIC SURGERY MACHINE (June 14, 2012)
  • K060171 — CLEANSE S+ ULTRASONIC SCALER (March 29, 2006)

Other clearances for product code EBZ

  • K253461 — Demi Pro (October 14, 2025)
  • K242386 — Bluemoon (May 5, 2025)
  • K243921 — LED Curing Lights (DB686 HALO) (April 11, 2025)
  • K250009 — LED Curing Light (C01-X, C02-X) (April 10, 2025)
  • K241238 — LOOP™ LED Curing Light System (CLK01) (August 1, 2024)
  • K223414 — Curing Light, Model: MaxCure 9 (November 15, 2023)
  • K233518 — BASE290 LED Curing Light (November 2, 2023)
  • K223507 — CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) (August 4, 2023)
  • K223142 — Coltolux Comfort LED Curing Light (December 22, 2022)
  • K220826 — LED Curing Light (December 8, 2022)