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510(k) K935390

SIROLUX FANTASTIC by Pelton & Crane Co. — Product Code EAZ

K935390 is an FDA 510(k) premarket notification submitted by Pelton & Crane Co. for the device "SIROLUX FANTASTIC". The FDA issued a decision of Substantially Equivalent on December 10, 1993. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Pelton & Crane Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1993
Date Received
November 8, 1993
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 Pelton & Crane Co.

  • K171872 — P50 Series Dental Operative Unit and Accessories (April 26, 2018)
  • K143696 — Spirit (September 18, 2015)
  • K972249 — ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD (September 12, 1997)
  • K972168 — SIDEXIS DIGITAL RADIOGRAPHY SYSTEM (September 5, 1997)
  • K945117 — DELTA (February 28, 1997)
  • K962071 — SPIRIT S1/S2 (August 6, 1996)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K950299 — CEREC 2 (May 23, 1995)
  • K946187 — SPIRIT II AND SPIRIT TREATMENT CENTER (March 1, 1995)
  • K950030 — HELIODENT MD (February 3, 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)
  • K003995 — SPECULITE/ORALLITE (March 16, 2001)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • 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)
  • K902685 — DEFIANCE MODEL FUS 336 (September 17, 1990)

FDA data resources