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510(k) K231391

Combi Touch by Mectron S.P.A. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2023
Date Received
May 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Mectron S.P.A.

  • K251425 — turbodent touch (May 9, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K171326 — Piezosurgery White (April 13, 2018)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)
  • K153743 — PIEZOSURGERY PLUS (May 25, 2016)
  • K151248 — PIEZOSURGERY WHITE (September 4, 2015)
  • K151023 — COMPACT PIEZO LED (August 5, 2015)
  • K140965 — MULTIPIEZO PRO, MULTIPIEZO (August 20, 2014)
  • K132848 — PIEZOSURGERY FLEX (November 29, 2013)
  • K122322 — PIEZOSURGERY TOUCH (December 6, 2012)

Other clearances for product code ELC

  • K260773 — Varios Combi Pro2 (March 10, 2026)
  • K253254 — GBT Machine Airflow Prophylaxis Master (January 28, 2026)
  • K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170L (September 19, 2025)
  • K242317 — Integrated Endo System (Meet Endo-II) (February 13, 2025)
  • K233844 — OdneClean (August 8, 2024)
  • K240707 — Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY- (July 2, 2024)
  • 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)