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510(k) K884223

DENTAL LAMP HANDLE COVER by Steri-Shield Products, Inc. — Product Code EAZ

K884223 is an FDA 510(k) premarket notification submitted by Steri-Shield Products, Inc. for the device "DENTAL LAMP HANDLE COVER". The FDA issued a decision of Substantially Equivalent on March 17, 1989. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Steri-Shield Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1989
Date Received
October 6, 1988
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 Steri-Shield Products, Inc.

  • K884222 — CURING LIGHT COVER (March 17, 1989)
  • K884221 — ULTRASONIC SCALER COVER (March 17, 1989)
  • K884219 — BRACKET TABLE ARM COVER (March 17, 1989)
  • K884220 — AIR WATER SYRINGE TIP SHIELD (March 17, 1989)

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