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510(k) K003995

SPECULITE/ORALLITE by Trylon Corp. — Product Code EAZ

K003995 is an FDA 510(k) premarket notification submitted by Trylon Corp. for the device "SPECULITE/ORALLITE". The FDA issued a decision of Substantially Equivalent on March 16, 2001. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Trylon Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2001
Date Received
December 26, 2000
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 Trylon Corp.

  • K033033 — VIZILITE-BLUE ORAL EXAM KIT (November 22, 2004)
  • K011488 — SPIRABRUSH CX BIOPSY INSTRUMENT (February 22, 2002)
  • K012070 — ORALLITE COMPREHENSIVE EXAM TRAY (November 27, 2001)
  • K963391 — SPECULITE (December 12, 1997)
  • K955790 — PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY (March 21, 1996)
  • K953364 — SPECULITE (December 8, 1995)

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)
  • 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)
  • K902685 — DEFIANCE MODEL FUS 336 (September 17, 1990)

FDA data resources