Home / 510(k) Clearances / K242404

510(k) K242404

BDC Dental Unit by Bdc Dental Corporation , Ltd. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2025
Date Received
August 13, 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 by Bdc Dental Corporation , Ltd.

  • K203425 — Surgical Mask (March 5, 2021)

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)
  • K242611 — Integral Dental Units (May 27, 2025)
  • K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (February 19, 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)