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510(k) K832063

ROBIN CORDLESS HANDPIECE by Kaycor Intl., Ltd. — Product Code EKX

K832063 is an FDA 510(k) premarket notification submitted by Kaycor Intl., Ltd. for the device "ROBIN CORDLESS HANDPIECE". The FDA issued a decision of Substantially Equivalent on August 26, 1983. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Kaycor Intl., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1983
Date Received
June 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Kaycor Intl., Ltd.

  • K965072 — PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT (January 27, 1997)
  • K931717 — YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY (September 20, 1993)
  • K822740 — K30000 DENTAL CHAIR (September 28, 1982)
  • K813348 — YOSHIDA RIDO-F, MODEL LM-01 (January 7, 1982)
  • K811210 — YOSHIDA-PANOURA 10 (August 24, 1981)
  • K811211 — YOSHIDA AP 100 (June 16, 1981)

Other clearances for product code EKX

  • K252223 — Alpha Endo Handpiece (Alpha Endo) (October 16, 2025)
  • K251597 — InnerView System (September 18, 2025)
  • K243692 — EnDrive (EnDriveUS) (August 22, 2025)
  • K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (April 24, 2025)
  • K241065 — ChecQ (AC100) (March 21, 2025)
  • K243911 — HPR Cordless Hygiene Handpiece (December 20, 2024)
  • K222688 — The Trust (August 9, 2024)
  • K233865 — X-Smart Pro; X-Smart Pro+ (July 24, 2024)
  • K232551 — EM-07 Cordless Endo Motor (July 9, 2024)
  • K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit (November 9, 2023)

FDA data resources