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510(k) K233921

Luvis Chair (LC700C) by Dentis Co., Ltd. — Product Code KLC

K233921 is an FDA 510(k) premarket notification submitted by Dentis Co., Ltd. for the device "Luvis Chair (LC700C)". The FDA issued a decision of Substantially Equivalent on September 6, 2024. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Dentis Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2024
Date Received
December 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Dental, With Operative Unit
Device Class
Class I
Regulation Number
872.6250
Review Panel
DE
Submission Type

Other clearances by Dentis Co., Ltd.

  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K241065 — ChecQ (AC100) (March 21, 2025)
  • K241063 — s-Clean ScanHealing Abutment (July 25, 2024)
  • K240511 — Dentis s-Clean SQ-SL Fixture (May 20, 2024)
  • K233544 — MESHEET (February 22, 2024)
  • K230126 — Dentis s-Clean Regular Abutment (August 4, 2023)
  • K230307 — Dentis i-Clean System (July 11, 2023)
  • K230246 — Dentis s-Clean SQ-SL Narrow Implant System (May 25, 2023)
  • K230523 — s-Clean Link Abutment Narrow (May 24, 2023)
  • K230203 — Dentis I-FIX Abutment (May 3, 2023)

Other clearances for product code KLC

  • K151987 — DCI Edge Dental Chair with Operative Unit (June 1, 2016)
  • K071353 — FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C (December 14, 2007)
  • K971063 — OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR (June 3, 1997)
  • K963209 — PROSTYLE COMPACT (October 24, 1996)
  • K942870 — ULTIMA 2 DENTAL CHAIR (February 27, 1995)
  • K940950 — KAVO SYSTEMATICA 1060 (December 29, 1994)
  • K925567 — E 4000 DENTAL OPERATING CHAIR (March 10, 1994)
  • K923534 — PM2002 PROLINE (January 31, 1994)
  • K925119 — A-DEC 1040 CHAIR (January 31, 1994)
  • K925318 — A-DEC 2181 DUO UNIT (December 9, 1993)

FDA data resources