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510(k) K242611

Integral Dental Units by Mipont Medical Equipment Co., Ltd. — Product Code EIA

K242611 is an FDA 510(k) premarket notification submitted by Mipont Medical Equipment Co., Ltd. for the device "Integral Dental Units". The FDA issued a decision of Substantially Equivalent on May 27, 2025. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2025
Date Received
September 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances for product code EIA

  • K251626 — Midmark Dental Delivery System (November 3, 2025)
  • K251491 — K5 Cart, K5 Mount, K5 Swing (July 17, 2025)
  • K243130 — Integral Dental Unit (June 27, 2025)
  • K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (February 19, 2025)
  • K242404 — BDC Dental Unit (February 7, 2025)
  • K231297 — Firstar Dental Unit (January 27, 2025)
  • K233805 — K5 (September 3, 2024)
  • K240754 — N2 (March 21, 2024)
  • K231845 — Dental unit Model: Mare (February 28, 2024)
  • K202963 — ELEC Master, ELEC Master Dual (May 5, 2023)

FDA data resources