Home / 510(k) Clearances / K251811

510(k) K251811

Motor and Apex Module (MaAM) by Dentsply Sirona, Inc. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2025
Date Received
June 12, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Dentsply Sirona, Inc.

  • K253565 — SureSmile Software (March 4, 2026)
  • K251614 — Stainless Steel Surgical Kits (February 6, 2026)
  • K253959 — Primevision 3D (February 5, 2026)
  • K253009 — DS Core Detect (January 7, 2026)
  • K252343 — Atlantis® Abutments in Titanium (December 9, 2025)
  • K252248 — CEREC Tessera Abutment System (November 26, 2025)
  • K251205 — Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants (November 21, 2025)
  • K250771 — Primescan 2 (August 29, 2025)
  • K251647 — MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lanc (August 21, 2025)
  • K250755 — DS Core Diagnosis (August 12, 2025)

Other clearances for product code EBW

  • K251407 — Motor Handpiece and Control Unit (SDI10) (January 30, 2026)
  • K251701 — Star E900 Electric System (January 12, 2026)
  • K231562 — ELEC ENGINE (Model: ISE-170L) (July 18, 2025)
  • K242646 — Dental Implant Unit (April 11, 2025)
  • K233288 — NLZ Built-In Motor System (June 24, 2024)
  • K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (June 20, 2024)
  • K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3 (April 1, 2024)
  • K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 (March 11, 2024)
  • K211358 — Implanter incl. Accessories (November 21, 2022)
  • K220831 — Dental Implantation Systems, Dental Electrical Motors (September 27, 2022)