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510(k) K771249

JOY LIGHT by M.D. Intl., Inc. — Product Code EAZ

K771249 is an FDA 510(k) premarket notification submitted by M.D. Intl., Inc. for the device "JOY LIGHT". The FDA issued a decision of Substantially Equivalent on July 15, 1977. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. M.D. Intl., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1977
Date Received
July 7, 1977
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 M.D. Intl., Inc.

  • K894788 — DMI SERIES 90 EXAMINATION TABLE (September 8, 1989)
  • K894789 — DMI 250 SERIES POWER SURGERY TABLE (August 29, 1989)
  • K870832 — OXY-THERM (March 12, 1987)

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)
  • K923462 — DELIGHT (December 21, 1992)
  • K912997 — MINIFLEX AND PERSONAL UNIT (October 30, 1991)
  • K912142 — MICRONAIRE ISO-HOOD MAX 5UV (October 30, 1991)

FDA data resources