Home / 510(k) Clearances / K240950

510(k) K240950

Disposable Prophy Angle by Pacific Care Limited — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2025
Date Received
April 8, 2024
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances for product code EGS

  • K251869 — Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (September 15, 2025)
  • K240183 — Star E900 Handpiece Series (September 19, 2024)
  • K230106 — General Cutting Straight (May 24, 2023)
  • K222518 — FX Contra (November 17, 2022)
  • K220874 — Smooth Drive contra angle and straight handpieces (November 7, 2022)
  • K220346 — Lotus Prophy Angle (November 7, 2022)
  • K220577 — Dental Handpiece, Model CA160, CA160L, and CA500L (July 29, 2022)
  • K213139 — SURGmatic S15 L Pro (December 21, 2021)
  • K202960 — General Cutting Contra Handpiece (October 27, 2020)
  • K182892 — TRAUS Dental Handpieces (November 26, 2019)