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510(k) K250473

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus by Dci International, LLC — Product Code EIA

K250473 is an FDA 510(k) premarket notification submitted by Dci International, LLC for the device "Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus". The FDA issued a decision of Substantially Equivalent on February 19, 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
February 19, 2025
Date Received
February 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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

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  • K251491 — K5 Cart, K5 Mount, K5 Swing (July 17, 2025)
  • K243130 — Integral Dental Unit (June 27, 2025)
  • K242611 — Integral Dental Units (May 27, 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