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510(k) K923462

DELIGHT by Planmeca USA, Inc. — Product Code EAZ

K923462 is an FDA 510(k) premarket notification submitted by Planmeca USA, Inc. for the device "DELIGHT". The FDA issued a decision of Substantially Equivalent on December 21, 1992. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Planmeca USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1992
Date Received
July 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Operating, Dental
Device Class
Class I
Regulation Number
872.4630
Review Panel
DE
Submission Type

Other clearances by Planmeca USA, Inc.

  • K111361 — PLANMED NUANCE EXCEL (September 23, 2011)
  • K081699 — PLANMECA SOVEREIGN (August 29, 2008)
  • K923534 — PM2002 PROLINE (January 31, 1994)
  • K923533 — ADMARK (March 4, 1993)
  • K923461 — PM2002 PROLINE, PM2002 PROLINE EC (December 21, 1992)
  • K904953 — PLANMED SOPHIE (April 18, 1991)
  • K904948 — PM2002 CC AND PM2002 EC (January 30, 1991)
  • K904947 — PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE (January 30, 1991)
  • K864474 — DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC (November 26, 1986)
  • K842359 — AUTOMATIC PATIENT CHAIR PM2000 & A (September 19, 1984)

Other clearances for product code EAZ

  • K072309 — MICROLUX/BLU (November 19, 2007)
  • K041614 — MICROLUX DL (April 4, 2005)
  • K033033 — VIZILITE-BLUE ORAL EXAM KIT (November 22, 2004)
  • K003995 — SPECULITE/ORALLITE (March 16, 2001)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K935390 — SIROLUX FANTASTIC (December 10, 1993)
  • K925629 — ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (November 23, 1993)
  • K912142 — MICRONAIRE ISO-HOOD MAX 5UV (October 30, 1991)
  • K912997 — MINIFLEX AND PERSONAL UNIT (October 30, 1991)
  • K902685 — DEFIANCE MODEL FUS 336 (September 17, 1990)

FDA data resources