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510(k) K191079

Piezon Built-in Kit, Piezon Built-in Kit LED by E.M.S Electro Medical Systems S.A — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2019
Date Received
April 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

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  • K240801 — BioSonic US200 Ultrasonic Scaler (60034537) (July 1, 2024)
  • K233922 — SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CO (March 11, 2024)
  • K223340 — EDS Calculus Softener TURBO CR (December 11, 2023)
  • K230641 — Ultrasonic Scaler Tips (November 21, 2023)