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510(k) K260773

Varios Combi Pro2 by Nakanishi, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2026
Date Received
March 9, 2026
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

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Other clearances for product code ELC

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  • 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)
  • K223173 — Proxeo ULTRA (PB-510, PB-520 and PB-530) (July 14, 2023)