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510(k) K801683

LUNA-VUE DENTAL OPERATING LIGHT by Pacific Dental Corp. — Product Code EAZ

K801683 is an FDA 510(k) premarket notification submitted by Pacific Dental Corp. for the device "LUNA-VUE DENTAL OPERATING LIGHT". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Pacific Dental Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1980
Date Received
July 21, 1980
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 Pacific Dental Corp.

  • K821782 — BEACH ANESTHETIC SYRINGE CARTR. TYPE (July 20, 1982)
  • K821783 — BEACH SILICATE FILLING & LINING APPLIC. (July 6, 1982)
  • K821787 — BEACH SURGICAL PLIERS NON-HOOK (July 6, 1982)
  • K821790 — BEACH EXCAVATOR'S NO. 1 & NO. 2 (July 6, 1982)
  • K821786 — BEACH SCALERS (July 6, 1982)
  • K821789 — BEACH CURETTE NO. 2 AND NO. 3 T.G. (July 6, 1982)
  • K821784 — BEACH GINGIVAL RETRACTION INSTR. TYPE B (July 6, 1982)
  • K821788 — BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT (July 6, 1982)
  • K821777 — BEACH MOUTH MIRROR (July 6, 1982)
  • K821780 — BEACH EXPLORER NO. 23T.G. (July 6, 1982)

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

FDA data resources